Trial Outcomes & Findings for A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis (NCT NCT01696279)
NCT ID: NCT01696279
Last Updated: 2021-06-10
Results Overview
KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (\>=) 12 to less than (\<) 18 years to be less than or equal to (\<=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter \[mmol/L\]); Children aged \>=10 years to \<12 years to be \<= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3
Results posted on
2021-06-10
Participant Flow
The study was conducted at 23 study centers between 15 February 2013 (first participant first visit) and 16 November 2018 (last participant last visit).
It was a 3 part study (Part 1: Pharmacokinetic assessment, Part 2: \[Part 2a-calcium carbonate and lanthanum carbonate {crossover comparison} or Part 2b-lanthanum carbonate\], Part 3: lanthanum carbonate treatment for 6 months). Overall 63 participants enrolled in the study.
Participant milestones
| Measure |
Part 1: Single Dose Lanthanum Carbonate
Participants aged 10 to 12 years received 500 milligram (mg) and greater than (\>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder in the morning following breakfast.
|
Part 2a: Calcium Carbonate, Then Lanthanum Carbonate (8 Weeks)
Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks calcium carbonate, followed by 3 weeks of washout period (if necessary). At the end of first 8-week treatment period of part 2a, participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks lanthanum carbonate treatment period.
|
Part 2b: Lanthanum Carbonate (8 Weeks)
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
Part 3: Lanthanum Carbonate (6 Months)
Participants who completed in Part 2 (2a or 2b) could continue to receive lanthanum carbonate for an additional 6 months. Dosage of lanthanum carbonate was determined by the investigator based on serum phosphate levels taken at each study visit up to a maximum dose of 3000 mg/day.
|
|---|---|---|---|---|
|
Part 1: Single Dose Lanthanum Carbonate
STARTED
|
20
|
0
|
0
|
0
|
|
Part 1: Single Dose Lanthanum Carbonate
Safety Analysis Set 1
|
20
|
0
|
0
|
0
|
|
Part 1: Single Dose Lanthanum Carbonate
Entered Part 2a
|
19
|
0
|
0
|
0
|
|
Part 1: Single Dose Lanthanum Carbonate
COMPLETED
|
19
|
0
|
0
|
0
|
|
Part 1: Single Dose Lanthanum Carbonate
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
STARTED
|
0
|
53
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Safety Completer Set
|
0
|
37
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Full Analysis Set
|
0
|
53
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Per-protocol Set 1
|
0
|
17
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Per-protocol Set 2
|
0
|
25
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Entered Part 3
|
0
|
34
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
COMPLETED
|
0
|
34
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
NOT COMPLETED
|
0
|
19
|
0
|
0
|
|
Part 2b: Lanthanum Carbonate (8 Weeks)
STARTED
|
0
|
0
|
9
|
0
|
|
Part 2b: Lanthanum Carbonate (8 Weeks)
Safety Completer Set
|
0
|
0
|
9
|
0
|
|
Part 2b: Lanthanum Carbonate (8 Weeks)
Full Analysis Set
|
0
|
0
|
9
|
0
|
|
Part 2b: Lanthanum Carbonate (8 Weeks)
Per-protocol Set 1
|
0
|
0
|
0
|
0
|
|
Part 2b: Lanthanum Carbonate (8 Weeks)
Per-protocol Set 2
|
0
|
0
|
9
|
0
|
|
Part 2b: Lanthanum Carbonate (8 Weeks)
COMPLETED
|
0
|
0
|
8
|
0
|
|
Part 2b: Lanthanum Carbonate (8 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Part 3: Lanthanum Carbonate (6 Months)
STARTED
|
0
|
0
|
0
|
42
|
|
Part 3: Lanthanum Carbonate (6 Months)
COMPLETED
|
0
|
0
|
0
|
34
|
|
Part 3: Lanthanum Carbonate (6 Months)
NOT COMPLETED
|
0
|
0
|
0
|
8
|
Reasons for withdrawal
| Measure |
Part 1: Single Dose Lanthanum Carbonate
Participants aged 10 to 12 years received 500 milligram (mg) and greater than (\>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder in the morning following breakfast.
|
Part 2a: Calcium Carbonate, Then Lanthanum Carbonate (8 Weeks)
Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks calcium carbonate, followed by 3 weeks of washout period (if necessary). At the end of first 8-week treatment period of part 2a, participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks lanthanum carbonate treatment period.
|
Part 2b: Lanthanum Carbonate (8 Weeks)
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
Part 3: Lanthanum Carbonate (6 Months)
Participants who completed in Part 2 (2a or 2b) could continue to receive lanthanum carbonate for an additional 6 months. Dosage of lanthanum carbonate was determined by the investigator based on serum phosphate levels taken at each study visit up to a maximum dose of 3000 mg/day.
|
|---|---|---|---|---|
|
Part 1: Single Dose Lanthanum Carbonate
Kidney Transplant
|
1
|
0
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Adverse Event
|
0
|
5
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Other (Unspecified)
|
0
|
3
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Kidney Transplant
|
0
|
7
|
0
|
0
|
|
Part 2a: Calcium Carbonate + Lanthanum
Non-Compliance with Study Drug
|
0
|
2
|
0
|
0
|
|
Part 2b: Lanthanum Carbonate (8 Weeks)
Kidney Transplant
|
0
|
0
|
1
|
0
|
|
Part 3: Lanthanum Carbonate (6 Months)
Kidney transplant
|
0
|
0
|
0
|
6
|
|
Part 3: Lanthanum Carbonate (6 Months)
Other (Unspecified)
|
0
|
0
|
0
|
1
|
|
Part 3: Lanthanum Carbonate (6 Months)
Missing
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
Baseline characteristics by cohort
| Measure |
Overall Study
n=63 Participants
Study was conducted in 3 parts, participants aged 10 to 12 years received 500 milligram (mg) and greater than (\>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder respectively during part 1, followed by part 2 during which participants received calcium carbonate tablet for 8 weeks until a maximum daily dose of 6500 mg was reached (part 2a-Treatment period 1) and then received lanthanum carbonate oral powder for 8 weeks until a daily dose of 1500 mg was reached (part 2a-Treatment period 2). Eligible participants received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg, which was titrated bi-weekly until a daily dose of 3000 mg was achieved (part 2b). Participants who completed part 2 continued the same treatment for additional 6 months during the part 3.
|
|---|---|
|
Age, Continuous
|
13.1 Year
STANDARD_DEVIATION 2.65 • n=5 Participants
|
|
Age, Customized
Age group: < 10 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
Age group: ≥10 to <12 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
Age group: ≥12 to <18 years
|
49 Participants
n=5 Participants
|
|
Age, Customized
Age group: ≥18 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3Population: Per-protocol set 2 (PP2) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (\>=) 12 to less than (\<) 18 years to be less than or equal to (\<=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter \[mmol/L\]); Children aged \>=10 years to \<12 years to be \<= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=34 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)
|
50 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 19 weeksPopulation: Per Protocol Set 1 (PP1) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
KDOQI serum phosphorus targets was defined for: Adolescents aged \>= 12 \< 18 years to be \<= 5.5 mg/dL (1.78 \[mmol/L\]); Children aged \>=10 years to \<12 years to be \<= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level were reported only for the participants who had received calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate in Part 2. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2
|
58.8 Percentage of participants
|
70.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=34 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks
|
-0.334 millimoles per liter (mmol/L)
Standard Error 0.1035
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=34 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8
|
-0.001 millimole per liter (mmol/L)
Standard Error 0.0363
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome measure was millimole square per square liter (mmol\^2/L\^2). Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=34 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8
|
-0.577 mmol^2/L^2
Standard Error 0.2464
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=16 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
|
-0.520 millimole per liter (mmol/L)
Standard Error 0.1786
|
-0.467 millimole per liter (mmol/L)
Standard Error 0.1312
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=16 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
|
0.058 millimole per liter (mmol/L)
Standard Error 0.0554
|
-0.009 millimole per liter (mmol/L)
Standard Error 0.0574
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome was millimole square per square liter. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=16 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
|
-0.966 mmol^2/L^2
Standard Error 0.4084
|
-0.669 mmol^2/L^2
Standard Error 0.3834
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in serum phosphorus levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=34 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 8
|
-0.334 millimole per liter (mmol/L)
Standard Deviation 0.1035
|
—
|
|
Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 12
|
-0.416 millimole per liter (mmol/L)
Standard Deviation 0.0912
|
—
|
|
Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 16
|
-0.314 millimole per liter (mmol/L)
Standard Deviation 0.1278
|
—
|
|
Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 20
|
-0.316 millimole per liter (mmol/L)
Standard Deviation 0.1055
|
—
|
|
Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 24
|
-0.322 millimole per liter (mmol/L)
Standard Deviation 0.1356
|
—
|
|
Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 28
|
-0.236 millimole per liter (mmol/L)
Standard Deviation 0.1491
|
—
|
|
Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 32
|
-0.143 millimole per liter (mmol/L)
Standard Deviation 0.1558
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in calcium levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6- month extension phase (Part 3) were reported.Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=34 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 24
|
-0.010 millimole per liter (mmol/L)
Standard Error 0.0450
|
—
|
|
Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 28
|
0.049 millimole per liter (mmol/L)
Standard Error 0.0623
|
—
|
|
Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 32
|
-0.127 millimole per liter (mmol/L)
Standard Error 0.0773
|
—
|
|
Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 8
|
-0.001 millimole per liter (mmol/L)
Standard Error 0.0363
|
—
|
|
Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 12
|
-0.045 millimole per liter (mmol/L)
Standard Error 0.0475
|
—
|
|
Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 16
|
-0.034 millimole per liter (mmol/L)
Standard Error 0.0534
|
—
|
|
Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 20
|
0.003 millimole per liter (mmol/L)
Standard Error 0.0511
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in calcium-phosphorus product levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. The unit of measure of this outcome was millimole square per square liter. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=34 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 32
|
-0.570 mmol^2/L^2
Standard Error 0.3624
|
—
|
|
Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 8
|
-0.577 mmol^2/L^2
Standard Error 0.2464
|
—
|
|
Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 12
|
-0.783 mmol^2/L^2
Standard Error 0.2535
|
—
|
|
Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 16
|
-0.575 mmol^2/L^2
Standard Error 0.3023
|
—
|
|
Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 20
|
-0.362 mmol^2/L^2
Standard Error 0.2711
|
—
|
|
Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 24
|
-0.578 mmol^2/L^2
Standard Error 0.3459
|
—
|
|
Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
Change at Week 28
|
-0.326 mmol^2/L^2
Standard Error 0.3767
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in bone turnover markers including bone alkaline phosphatase (ALP), osteocalcin, and sclerostin was reported for combined Part 2 and 3. End of the study (EOS) was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Biochemical Bone Markers
ALP : Change at Week 8
|
-0.78 microgram per liter (ug/L)
Standard Error 8.503
|
—
|
|
Change From Baseline in Biochemical Bone Markers
ALP : Change at Week 16
|
—
|
31.86 microgram per liter (ug/L)
Standard Error 16.334
|
|
Change From Baseline in Biochemical Bone Markers
ALP : Change at EOS
|
—
|
59.12 microgram per liter (ug/L)
Standard Error 20.822
|
|
Change From Baseline in Biochemical Bone Markers
Osteocalcin: Change at Week 8
|
8.2 microgram per liter (ug/L)
Standard Error 20.24
|
—
|
|
Change From Baseline in Biochemical Bone Markers
Osteocalcin: Change at Week 16
|
—
|
10.3 microgram per liter (ug/L)
Standard Error 21.57
|
|
Change From Baseline in Biochemical Bone Markers
Osteocalcin: Change at EOS
|
—
|
94.0 microgram per liter (ug/L)
Standard Error 32.60
|
|
Change From Baseline in Biochemical Bone Markers
Sclerostin: Change at Week 8
|
0.146 microgram per liter (ug/L)
Standard Error 0.1380
|
—
|
|
Change From Baseline in Biochemical Bone Markers
Sclerostin: Change at Week 16
|
—
|
-0.062 microgram per liter (ug/L)
Standard Error 0.0946
|
|
Change From Baseline in Biochemical Bone Markers
Sclerostin: Change at EOS
|
—
|
-0.051 microgram per liter (ug/L)
Standard Error 0.1037
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in bone turnover markers for, tartrate-resistant acid phosphatase (TRAP) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)
Change at Week 8
|
-1.71 unit per liter (U/L)
Standard Error 1.141
|
—
|
|
Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)
Change at Week 16
|
—
|
1.95 unit per liter (U/L)
Standard Error 1.173
|
|
Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)
Change at EOS
|
—
|
4.65 unit per liter (U/L)
Standard Error 1.934
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in bone turnover markers including fibroblast growth factor 23 (FGF-23) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)
Change at Week 8
|
5130.3 relative unit per milliliter (RU/ml)
Standard Error 5232.21
|
—
|
|
Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)
Change at Week 16
|
—
|
-8162.4 relative unit per milliliter (RU/ml)
Standard Error 5274.60
|
|
Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)
Change at EOS
|
—
|
-251.1 relative unit per milliliter (RU/ml)
Standard Error 1736.51
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in bone turnover markers for parathyroid hormone was reported for combined Part 2 and 3. End of the study is the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)
Change at Week 8
|
-7.132 picomole per litre (pmol/L)
Standard Error 9.7669
|
—
|
|
Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)
Change at Week 16
|
—
|
16.273 picomole per litre (pmol/L)
Standard Error 12.5441
|
|
Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)
Change at EOS
|
—
|
59.801 picomole per litre (pmol/L)
Standard Error 16.3097
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in bone turnover markers for fetuin-A was reported for combined Part 2 and 3. End of the study is the completion if the participants has benefited from and desires to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Biochemical Bone Markers for Fetuin-A
Change at EOS
|
—
|
0.039 gram per liter (g/L)
Standard Error 0.0273
|
|
Change From Baseline in Biochemical Bone Markers for Fetuin-A
Changed at Week 8
|
-0.006 gram per liter (g/L)
Standard Error 0.0301
|
—
|
|
Change From Baseline in Biochemical Bone Markers for Fetuin-A
Change at Week 16
|
—
|
0.037 gram per liter (g/L)
Standard Error 0.0360
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in height for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Height
Change at Week 8
|
0.7 centimeter (cm)
Standard Error 0.39
|
—
|
|
Change From Baseline in Height
Change at Week 16
|
—
|
0.6 centimeter (cm)
Standard Error 0.25
|
|
Change From Baseline in Height
Change at EOS
|
—
|
1.3 centimeter (cm)
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
Change from baseline in weight for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
Outcome measures
| Measure |
Part 2 + Part 3: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
Part 2: Lanthanum Carbonate
n=17 Participants
Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).
|
|---|---|---|
|
Change From Baseline in Weight
Change at Week 16
|
—
|
1.09 kilogram (Kg)
Standard Error 0.358
|
|
Change From Baseline in Weight
Change at Week 8
|
1.18 kilogram (Kg)
Standard Error 0.524
|
—
|
|
Change From Baseline in Weight
Change at EOS
|
—
|
2.86 kilogram (Kg)
Standard Error 0.606
|
Adverse Events
Part 1: Lanthanum Carbonate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: Calcium Carbonate
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2 + Part 3: Lanthanum Carbonate
Serious events: 19 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Lanthanum Carbonate
n=20 participants at risk
Participants aged 10 to 12 years received 500 mg and greater than (\>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder.
|
Part 2: Calcium Carbonate
n=53 participants at risk
Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).
|
Part 2 + Part 3: Lanthanum Carbonate
n=52 participants at risk
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
3.8%
2/53 • Number of events 2 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
General disorders
Device occlusion
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/53 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
General disorders
Thrombosis in device
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/53 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/52 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Infections and infestations
Device related infection
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
3.8%
2/52 • Number of events 3 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
9.6%
5/52 • Number of events 6 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/53 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/52 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/53 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Injury, poisoning and procedural complications
Graft haemorrhage
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/53 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/52 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Investigations
Blood phosphorus
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/53 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/52 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/53 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/52 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 3 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/52 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/53 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/52 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
Other adverse events
| Measure |
Part 1: Lanthanum Carbonate
n=20 participants at risk
Participants aged 10 to 12 years received 500 mg and greater than (\>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder.
|
Part 2: Calcium Carbonate
n=53 participants at risk
Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).
|
Part 2 + Part 3: Lanthanum Carbonate
n=52 participants at risk
Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
3.8%
2/53 • Number of events 2 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
5.8%
3/52 • Number of events 5 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
1.9%
1/53 • Number of events 2 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
9.6%
5/52 • Number of events 6 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
5.7%
3/53 • Number of events 4 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
3.8%
2/52 • Number of events 2 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
9.6%
5/52 • Number of events 5 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
17.0%
9/53 • Number of events 9 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
9.6%
5/52 • Number of events 9 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
5.7%
3/53 • Number of events 3 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
5.8%
3/52 • Number of events 6 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/20 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
5.7%
3/53 • Number of events 4 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
11.5%
6/52 • Number of events 9 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/53 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
0.00%
0/52 • From start of study drug administration up to 42 Weeks
SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually
- Publication restrictions are in place
Restriction type: OTHER