Trial Outcomes & Findings for Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation (NCT NCT01401478)
NCT ID: NCT01401478
Last Updated: 2014-03-03
Results Overview
The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.
Recruitment status
COMPLETED
Target enrollment
86 participants
Primary outcome timeframe
6 months
Results posted on
2014-03-03
Participant Flow
Participant milestones
| Measure |
Stage 5 Chronic Kidney Disease
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Overall Study
STARTED
|
86
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Stage 5 Chronic Kidney Disease
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Overall Study
Study drug not available
|
6
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Hyperphosphatemia
|
5
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Kidney transplantation
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Blood samples not available
|
1
|
|
Overall Study
Hyperphosphatemia and adverse event
|
1
|
|
Overall Study
Low intact parathyroid hormone
|
1
|
|
Overall Study
Serious adverse event
|
1
|
Baseline Characteristics
Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
Baseline characteristics by cohort
| Measure |
Stage 5 Chronic Kidney Disease
n=86 Participants
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
86 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.4 Participants
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
86 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.
Outcome measures
| Measure |
Stage 5 Chronic Kidney Disease
n=86 Participants
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study
|
60.5 Percentage of participants
Interval 49.3 to 70.8
|
SECONDARY outcome
Timeframe: 6 monthsThe percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.
Outcome measures
| Measure |
Stage 5 Chronic Kidney Disease
n=86 Participants
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study
Baseline
|
57.0 Percentage of participants
Interval 45.8 to 67.6
|
|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study
Post-baseline
|
87.2 Percentage of participants
Interval 78.3 to 93.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis for this outcome was based on the number of participants (55) who completed the study.
The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.
Outcome measures
| Measure |
Stage 5 Chronic Kidney Disease
n=55 Participants
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
Baseline
|
49.1 Percentage of participants
Interval 35.4 to 62.9
|
|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
Visit 1
|
65.5 Percentage of participants
Interval 51.4 to 77.8
|
|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
Visit 2
|
45.5 Percentage of participants
Interval 32.0 to 59.4
|
|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
Visit 3
|
67.3 Percentage of participants
Interval 53.3 to 79.3
|
|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
Visit 4
|
40.0 Percentage of participants
Interval 27.0 to 54.1
|
|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
Visit 5
|
41.8 Percentage of participants
Interval 28.7 to 55.9
|
|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
Visit 6
|
49.1 Percentage of participants
Interval 35.4 to 62.9
|
SECONDARY outcome
Timeframe: 6 monthsThe percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.
Outcome measures
| Measure |
Stage 5 Chronic Kidney Disease
n=86 Participants
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study
|
38.4 Percentage of participants
Interval 28.1 to 49.5
|
SECONDARY outcome
Timeframe: 6 monthsThe percentage of participants who developed elevated calcium (Ca) x phosphate (P) (\> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.
Outcome measures
| Measure |
Stage 5 Chronic Kidney Disease
n=86 Participants
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
Visit 1
|
12.8 Percentage of participants
Interval 6.6 to 21.7
|
|
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
Visit 2
|
16.3 Percentage of participants
Interval 9.2 to 25.8
|
|
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
Visit 3
|
16.3 Percentage of participants
Interval 9.2 to 25.8
|
|
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
Visit 4
|
4.7 Percentage of participants
Interval 1.3 to 11.5
|
|
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
Visit 5
|
7.0 Percentage of participants
Interval 2.6 to 14.6
|
|
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
Visit 6
|
8.1 Percentage of participants
Interval 3.3 to 16.1
|
SECONDARY outcome
Timeframe: 6 monthsThe percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at least once post-baseline during the study was recorded.
Outcome measures
| Measure |
Stage 5 Chronic Kidney Disease
n=86 Participants
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study
|
10.5 Percentage of participants
Interval 4.9 to 18.9
|
SECONDARY outcome
Timeframe: 6 monthsThe percentage of participants who developed elevated normalized total calcium (\> 11.2 mg/dL) at each visit post-baseline during the study was recorded.
Outcome measures
| Measure |
Stage 5 Chronic Kidney Disease
n=86 Participants
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
Visit 1
|
1.2 Percentage of participants
Interval 0.0 to 6.3
|
|
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
Visit 2
|
2.3 Percentage of participants
Interval 0.3 to 8.1
|
|
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
Visit 3
|
2.3 Percentage of participants
Interval 0.3 to 8.1
|
|
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
Visit 4
|
4.7 Percentage of participants
Interval 1.3 to 11.5
|
|
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
Visit 5
|
2.3 Percentage of participants
Interval 0.3 to 8.1
|
|
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
Visit 6
|
0 Percentage of participants
Since there were no participants with elevated normalized total calcium at Visit 6, the 95% Confidence Interval is not applicable.
|
SECONDARY outcome
Timeframe: 6 monthsThe percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks.
Outcome measures
| Measure |
Stage 5 Chronic Kidney Disease
n=86 Participants
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination
Hypercalcemia
|
0 Percentage of participants
Since there were no participants with a calcium level greater than 11.2 mg/dL for more than 8 weeks during the study, the 95% Confidence Interval is not applicable.
|
|
Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination
Hyperphosphatemia
|
7.0 Percentage of participants
Interval 2.6 to 14.6
|
Adverse Events
Stage 5 Chronic Kidney Disease
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 5 Chronic Kidney Disease
n=86 participants at risk
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Vascular disorders
Circulatory collapse
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
|
Vascular disorders
Hypertension
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
|
Injury, poisoning and procedural complications
Post procedural hematoma
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
Other adverse events
| Measure |
Stage 5 Chronic Kidney Disease
n=86 participants at risk
Planned for Zemplar administration due to secondary hyperparathyroidism
|
|---|---|
|
Nervous system disorders
Restless legs syndrome
|
2.3%
2/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
|
Nervous system disorders
Headache
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
1.2%
1/86 • Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER