Trial Outcomes & Findings for Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience (NCT NCT01083186)

NCT ID: NCT01083186

Last Updated: 2013-03-12

Results Overview

iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the overall study population.

• Recruitment status: COMPLETED
• Target enrollment: 500 participants
• Primary outcome timeframe: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
• Results posted on: 2013-03-12

Participant Flow

Participant milestones

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
Overall Study STARTED	500
Overall Study COMPLETED	406
Overall Study NOT COMPLETED	94

Reasons for withdrawal

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
Overall Study Lost to Follow-up	48
Overall Study Consent Withdrawal	7
Overall Study Death	3
Overall Study Adverse Event	3
Overall Study Lack of Efficacy	2
Overall Study Hemodialysis Initiation	28
Overall Study Administrative Reasons	2
Overall Study Non-compliance to Study Treatment	1

Baseline Characteristics

Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience

Baseline characteristics by cohort

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
Age Continuous	67.4 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	186 Participants n=5 Participants
Sex: Female, Male Male	314 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12

Population: Overall study population. n=number of participants with available data at given time-point.

iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the overall study population.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Before Study Treatment (Baseline); n=495	232.1 pg/mL Standard Deviation 168.2	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Visit 1 (Enrollment); n=497	200.1 pg/mL Standard Deviation 141.1	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Visit 2 (3 Months Post-Enrollment); n=432	166.6 pg/mL Standard Deviation 137.6	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Visit 3 (6 Months Post-Enrollment); n=405	157.3 pg/mL Standard Deviation 172.9	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Visit 4 (9 Months Post-Enrollment); n=378	135.2 pg/mL Standard Deviation 99.5	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Visit 5 (12 Months Post-Enrollment); n=368	119.4 pg/mL Standard Deviation 63.1	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Change from Baseline to Enrollment; n=492	-32.2 pg/mL Standard Deviation 96.0	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Change from Baseline to Visit 2; n=429	-62.6 pg/mL Standard Deviation 125.5	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Change from Baseline to Visit 3; n=402	-69.7 pg/mL Standard Deviation 172.4	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Change from Baseline to Visit 4; n=376	-85.4 pg/mL Standard Deviation 129.4	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Change from Baseline to Visit 5; n=364	-96.1 pg/mL Standard Deviation 130.8	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Change from Enrollment to Visit 2; n=430	-35.6 pg/mL Standard Deviation 93.2	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Change from Enrollment to Visit 3; n=404	-41.9 pg/mL Standard Deviation 150.4	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Change from Enrollment to Visit 4; n=378	-58.4 pg/mL Standard Deviation 112.4	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population Change from Enrollment to Visit 5; n=367	-72.4 pg/mL Standard Deviation 113.4	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12

Population: Participants with renal transplantation history. n=number of participants with available data at given time-point.

iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the subpopulation of renal transplanted participants.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=40 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Before Study Treatment (Baseline); n=40	321.5 pg/mL Standard Deviation 293.6	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Visit 1 (Enrollment); n=39	269.3 pg/mL Standard Deviation 214.5	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Visit 2 (3 Months Post-Enrollment); n=27	240.1 pg/mL Standard Deviation 166.0	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Visit 3 (6 Months Post-Enrollment); n=21	271.4 pg/mL Standard Deviation 225.2	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Visit 4 (9 Months Post-Enrollment); n=15	299.7 pg/mL Standard Deviation 231.9	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Visit 5 (12 Months Post-Enrollment); n=21	182.9 pg/mL Standard Deviation 109.6	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Change from Baseline to Enrollment; n=39	-50.1 pg/mL Standard Deviation 144.8	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Change from Baseline to Visit 2; n=27	-93.0 pg/mL Standard Deviation 134.8	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Change from Baseline to Visit 3; n=21	-95.4 pg/mL Standard Deviation 262.0	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Change from Baseline to Visit 4; n=15	-71.3 pg/mL Standard Deviation 228.2	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Change from Baseline to Visit 5; n=21	-92.5 pg/mL Standard Deviation 139.4	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Change from Enrollment to Visit 2; n=26	-61.3 pg/mL Standard Deviation 106.1	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Change from Enrollment to Visit 3; n=20	-72.1 pg/mL Standard Deviation 215.0	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Change from Enrollment to Visit 4; n=15	-69.0 pg/mL Standard Deviation 207.3	—	—	—	—
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants Change from Enrollment to Visit 5; n=20	-73.1 pg/mL Standard Deviation 144.6	—	—	—	—

SECONDARY outcome

Timeframe: Measured from start of study, up to a maximum of 12 months

Population: Subset of participants with baseline CKD stage ≥ 3 as well as with available iPTH values greater than the upper limit of the target range, prior to paricalcitol treatment onset. Target range for this specific analysis was defined based on patient's CKD stage (per baseline eGFR) prior to paricalcitol treatment onset.

The time to attain the first lower iPTH levels was considered as the time from the date of oral paricalcitol treatment onset until the date when any of the following conditions were initially met: a 30% reduction from iPTH levels prior to treatment onset had been achieved, for patients who were still outside the target range; or iPTH levels equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL; CKD Stage 5: ≤ 300 pg/mL).

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=470 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels	7.8 months Interval 7.2 to 8.5	—	—	—	—

SECONDARY outcome

Timeframe: Measured from start of study, up to a maximum of 12 months

Population: All evaluable participants

The effect was considered sustainable if: the participant's intact parathormone (iPTH) value remained equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL); or iPTH levels continued to decrease 30% from the previous available measurement.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=362 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Mean Duration of Effect Sustainability (Months)	3.8 months Standard Deviation 2.4	—	—	—	—

SECONDARY outcome

Timeframe: Enrollment Visit, Month 3, Month 6, Month 9, Month 12

Population: All participants. n=participants with evaluable data at given time point.

Number of participants with iPTH levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines at each study measurement after oral paricalcitol treatment onset. K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range n=500 Participants Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range Visit 1 (Enrollment); n=497	11 participants	486 participants	—	—	—
Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range Visit 2 (3 Months Post-Enrollment); n=432	75 participants	357 participants	—	—	—
Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range Visit 3 (6 Months Post-Enrollment); n=405	76 participants	329 participants	—	—	—
Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range Visit 4 (9 Months Post-Enrollment); n=378	89 participants	289 participants	—	—	—
Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range Visit 5 (12 Months Post-Enrollment); n=368	101 participants	267 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, Enrollment Visit, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-point.

Normal serum calcium range was 8.4-10.2 mg/dL.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range n=500 Participants Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Number of Participants With Serum Calcium Level Abnormalities Visit 1 (Enrollment); n=471	409 participants	62 participants	—	—	—
Number of Participants With Serum Calcium Level Abnormalities Visit 5 (12 Months Post-Enrollment); n=386	342 participants	44 participants	—	—	—
Number of Participants With Serum Calcium Level Abnormalities Before Study Treatment (Baseline); n=461	384 participants	77 participants	—	—	—
Number of Participants With Serum Calcium Level Abnormalities Visit 3 (6 Months Post-Enrollment); n=436	391 participants	45 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, Enrollment Visit, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-point

Normal serum phosphorus range was 2.7-4.6 mg/dL.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range n=500 Participants Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Number of Participants With Serum Phosphorus Level Abnormalities Before Study Treatment (Baseline); n=451	367 participants	84 participants	—	—	—
Number of Participants With Serum Phosphorus Level Abnormalities Visit 1 (Enrollment); n=466	361 participants	105 participants	—	—	—
Number of Participants With Serum Phosphorus Level Abnormalities Visit 3 (6 Months Post-Enrollment); n=429	326 participants	103 participants	—	—	—
Number of Participants With Serum Phosphorus Level Abnormalities Visit 5 (12 Months Post-Enrollment); n=375	271 participants	104 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: Number of participants with evaluable data at both Baseline and Visit 3 (6 Months Post-Enrollment)

The values "-, Trace, +, ++, and +++" are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=162 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range n=162 Participants Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 n=162 Participants The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 n=162 Participants The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 n=162 Participants The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change in Dipstick Albuminuria Grade From Baseline to Month 6 Grade "-" at Baseline	19 participants	1 participants	10 participants	2 participants	0 participants
Change in Dipstick Albuminuria Grade From Baseline to Month 6 Grade "Trace" at Baseline	1 participants	0 participants	1 participants	0 participants	0 participants
Change in Dipstick Albuminuria Grade From Baseline to Month 6 Grade "+" at Baseline	15 participants	1 participants	36 participants	10 participants	3 participants
Change in Dipstick Albuminuria Grade From Baseline to Month 6 Grade "++" at Baseline	2 participants	0 participants	9 participants	18 participants	4 participants
Change in Dipstick Albuminuria Grade From Baseline to Month 6 Grade "+++" at Baseline	0 participants	2 participants	7 participants	6 participants	15 participants

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: Number of participants with evaluable data at both Baseline and Visit 5 (12 Months Post-Enrollment)

The values "-, Trace, +, ++, and +++" are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=149 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range n=149 Participants Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 n=149 Participants The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 n=149 Participants The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 n=149 Participants The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change in Dipstick Albuminuria Grade From Baseline to Month 12 Grade "+++" at Baseline	0 participants	0 participants	6 participants	1 participants	20 participants
Change in Dipstick Albuminuria Grade From Baseline to Month 12 Grade "-" at Baseline	18 participants	3 participants	6 participants	3 participants	0 participants
Change in Dipstick Albuminuria Grade From Baseline to Month 12 Grade "Trace" at Baseline	0 participants	0 participants	1 participants	0 participants	0 participants
Change in Dipstick Albuminuria Grade From Baseline to Month 12 Grade "+" at Baseline	14 participants	1 participants	37 participants	9 participants	2 participants
Change in Dipstick Albuminuria Grade From Baseline to Month 12 Grade "++" at Baseline	2 participants	0 participants	8 participants	13 participants	5 participants

SECONDARY outcome

Timeframe: Baseline, Enrollment Visit, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The HbA1c normal range was 4.3-6.1%.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study Before Study Treatment (Baseline); n=101	7.2 percent Standard Deviation 1.6	—	—	—	—
Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study Visit 1 (Enrollment); n=99	6.9 percent Standard Deviation 1.4	—	—	—	—
Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study Visit 3 (6 Months Post-Enrollment); n=76	7.0 percent Standard Deviation 1.5	—	—	—	—
Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study Visit 5 (12 Months Post-Enrollment); n=69	6.9 percent Standard Deviation 1.2	—	—	—	—

SECONDARY outcome

Timeframe: From time of enrollment throughout the study up to 12 months for nSAEs. SAEs from time of enrollment throughout the study up to + 30 days after end of study.

Population: All participants

In order to establish the safety profile of oral paricalcitol in daily clinical practice, non-serious adverse events (nSAEs) and serious adverse events (SAEs) were collected during the course of the study. An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above. Please see Adverse Events section below for more details.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) Adverse Events (nSAEs and SAEs)	192 participants	—	—	—	—
Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) nSAEs	180 participants	—	—	—	—
Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) SAEs	19 participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

Change in CKD stage throughout the study period was assessed by the estimated glomerular filtration rate (eGFR) levels recorded by the physicians at each study time point. Classification of eGFR into CKD stages as follows: CKD stage 2: 60-89 mL/min/1.73m^2; CKD stage 3: 30-59 mL/min/1.73m^2; CKD stage 4: 15-29 mL/min/1.73m^2; CKD stage 5: <15 mL/min/1.73/m^2. Table presents the number of participants by stage at each study visit.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range n=500 Participants Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 n=500 Participants The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 n=500 Participants The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study Visit 1 (Enrollment); n=500	0 participants	234 participants	266 participants	0 participants	—
Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study Visit 2 (3 Months Post-Enrollment); n=463	2 participants	214 participants	214 participants	33 participants	—
Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study Visit 3 (6 Months Post-Enrollment); n=451	3 participants	197 participants	210 participants	41 participants	—
Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study Visit 4 (9 Months Post-Enrollment); n=426	3 participants	190 participants	185 participants	48 participants	—
Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study Visit 5 (12 Months Post-Enrollment); n=406	1 participants	175 participants	184 participants	46 participants	—

SECONDARY outcome

Timeframe: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The eGFR normal range was 90-120 mL/min/1.73m^2.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study Before Study Treatment (Baseline); n=499	30.4 mL/min/1.73m^2 Standard Deviation 11.3	—	—	—	—
Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study Visit 1 (Enrollment); n=500	29.9 mL/min/1.73m^2 Standard Deviation 11.3	—	—	—	—
Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study Visit 2 (3 Months Post-Enrollment); n=463	29.6 mL/min/1.73m^2 Standard Deviation 12.2	—	—	—	—
Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study Visit 3 (6 Months Post-Enrollment); n=451	29.6 mL/min/1.73m^2 Standard Deviation 12.4	—	—	—	—
Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study Visit 4 (9 Months Post-Enrollment); n=426	29.6 mL/min/1.73m^2 Standard Deviation 12.6	—	—	—	—
Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study Visit 5 (12 Months Post-Enrollment); n=406	29.1 mL/min/1.73m^2 Standard Deviation 12.4	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The alanine aminotransferase normal range was 11-43 IU/L.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12 Before Study Treatment (Baseline); n=367	20.2 IU/L Standard Deviation 10.2	—	—	—	—
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12 Change from Baseline to Visit 3 (6 Months); n=276	-0.4 IU/L Standard Deviation 11.0	—	—	—	—
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12 Change from Baseline to Visit 5 (12 months); n=259	0.3 IU/L Standard Deviation 11.3	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The aspartate aminotransferase normal range was 11-38 IU/L.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12 Before Study Treatment (Baseline); n=365	21.1 IU/L Standard Deviation 10.3	—	—	—	—
Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12 Change from Baseline to Visit 3 (6 Months); n=276	0.0 IU/L Standard Deviation 10.6	—	—	—	—
Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12 Change from Baseline to Visit 5 (12 months); n=257	-0.9 IU/L Standard Deviation 10.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The creatinine normal range was 0.6-1.4 mg/dL.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Baseline in Creatinine Levels at Months 6 and 12 Before Study Treatment (Baseline); n=499	2.4 mg/dL Standard Deviation 0.9	—	—	—	—
Change From Baseline in Creatinine Levels at Months 6 and 12 Change from Baseline to Visit 3 (6 Months); n=450	0.2 mg/dL Standard Deviation 0.8	—	—	—	—
Change From Baseline in Creatinine Levels at Months 6 and 12 Change from Baseline to Visit 5 (12 months); n=406	0.4 mg/dL Standard Deviation 0.9	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The urea normal range was 10-50 mg/dL.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Baseline in Urea Levels at Months 6 and 12 Before Study Treatment (Baseline); n=494	99.0 mg/dL Standard Deviation 40.3	—	—	—	—
Change From Baseline in Urea Levels at Months 6 and 12 Change from Baseline to Visit 3 (6 Months); n=443	2.2 mg/dL Standard Deviation 32.1	—	—	—	—
Change From Baseline in Urea Levels at Months 6 and 12 Change from Baseline to Visit 5 (12 months); n=399	7.2 mg/dL Standard Deviation 35.3	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The alkaline phosphatase normal range was 40-129 IU/L.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12 Before Study Treatment (Baseline); n=329	124.0 IU/L Standard Deviation 73.4	—	—	—	—
Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12 Change from Baseline to Visit 3 (6 Months); n=245	-5.0 IU/L Standard Deviation 49.3	—	—	—	—
Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12 Change from Baseline to Visit 5 (12 months); n=215	-10.3 IU/L Standard Deviation 62.4	—	—	—	—

SECONDARY outcome

Timeframe: Enrollment, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The total cholesterol normal range was 130-200 mg/dL.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Enrollment in Total Cholesterol Levels at Months 6 and 12 Visit 1 (Enrollment); n=367	186.3 mg/dL Standard Deviation 43.3	—	—	—	—
Change From Enrollment in Total Cholesterol Levels at Months 6 and 12 Change from Enrollment to Visit 3 (6 Months);n=272	-3.8 mg/dL Standard Deviation 38.1	—	—	—	—
Change From Enrollment in Total Cholesterol Levels at Months 6 and 12 Change from Enrollment to Visit 5(12 months);n=243	-5.4 mg/dL Standard Deviation 39.6	—	—	—	—

SECONDARY outcome

Timeframe: Enrollment, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The normal range for triglycerides was 0-200 mg/dL.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Enrollment in Triglyceride Levels at Months 6 and 12 Visit 1 (Enrollment); n=353	151.0 mg/dL Standard Deviation 80.5	—	—	—	—
Change From Enrollment in Triglyceride Levels at Months 6 and 12 Change from Baseline to Visit 3 (6 Months); n=259	-10.2 mg/dL Standard Deviation 56.0	—	—	—	—
Change From Enrollment in Triglyceride Levels at Months 6 and 12 Change from Baseline to Visit 5 (12 months); n=228	-10.3 mg/dL Standard Deviation 64.5	—	—	—	—

SECONDARY outcome

Timeframe: Enrollment, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The LDL-C normal range was 0-150 mg/dL.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12 Visit 1 (Enrollment); n=234	106.8 mg/dL Standard Deviation 42.8	—	—	—	—
Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12 Change from Baseline to Visit 3 (6 Months); n=144	-1.6 mg/dL Standard Deviation 36.2	—	—	—	—
Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12 Change from Baseline to Visit 5 (12 months); n=123	0.1 mg/dL Standard Deviation 48.3	—	—	—	—

SECONDARY outcome

Timeframe: Enrollment, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The HDL-C normal range was 35-90 mg/dL.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12 Enrollment (Visit 1); n=271	49.8 mg/dL Standard Deviation 16.6	—	—	—	—
Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12 Change from Baseline to Visit 3 (6 Months); n=193	-1.1 mg/dL Standard Deviation 18.7	—	—	—	—
Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12 Change from Baseline to Visit 5 (12 Months); n=166	-0.7 mg/dL Standard Deviation 20.2	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12

Population: All participants. n=number of participants with evaluable data at given time-points.

The CRP normal range was 0-0.6 mg/dL.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12 Before Study Treatment (Baseline); n=149	1.9 mg/dL Standard Deviation 3.3	—	—	—	—
Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12 Change from Baseline to Visit 3 (6 Months); n=110	-0.8 mg/dL Standard Deviation 2.6	—	—	—	—
Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12 Change from Baseline to Visit 5 (12 Months); n=101	0.5 mg/dL Standard Deviation 4.5	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Enrollment Visit, Month 6, Month 12

Population: All participants. n=the number of participants with evaluable data at given time-points.

The homocysteine normal range 3.5-20 μmol/L.

Outcome measures

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 Participants Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)	Participants Out of the iPTH Target Range Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.	"+" Albuminuria at Month 6 The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria.	"++" Albuminuria at Month 6 The value "++" is taken directly from the dipstick measurements, and represents the value second to highest albuminuria.	"+++" Albuminuria at Month 6 The value "+++" is taken directly from the dipstick measurements, and represents the highest albuminuria.
Homocysteine Values Throughout the Study Visit 4 (9 Months Post-Enrollment); n=17	24.7 μmol/L Standard Deviation 8.0	—	—	—	—
Homocysteine Values Throughout the Study Visit 5 (12 Months Post-Enrollment); n=13	22.4 μmol/L Standard Deviation 10.1	—	—	—	—
Homocysteine Values Throughout the Study Before Study Treatment (Baseline); n=16	24.8 μmol/L Standard Deviation 6.9	—	—	—	—
Homocysteine Values Throughout the Study Visit 1 (Enrollment); n=52	24.3 μmol/L Standard Deviation 9.5	—	—	—	—
Homocysteine Values Throughout the Study Visit 2 (3 Months Post-Enrollment); n=35	23.2 μmol/L Standard Deviation 7.5	—	—	—	—
Homocysteine Values Throughout the Study Visit 3 (6 Months Post-Enrollment); n=15	23.4 μmol/L Standard Deviation 8.2	—	—	—	—

Adverse Events

Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism

Serious events: 19 serious events

Other events: 168 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 participants at risk Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.80% 4/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.80% 4/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.40% 2/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Cardiac disorders Atrial fibrillation	0.40% 2/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Cardiac disorders Cardiac failure	0.40% 2/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Cardiac disorders Angina pectoris	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Cardiac disorders Cardiac arrest	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Cardiac disorders Coronary artery disease	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Cardiac disorders Coronary artery occlusion	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
General disorders Pyrexia	0.60% 3/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
General disorders Asthenia	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
General disorders Oedema peripheral	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
General disorders Ulcer	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
General disorders Unevaluable event	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Infections and infestations Pneumonia	0.40% 2/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Infections and infestations Respiratory tract infection	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Infections and infestations Urinary tract infection	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Renal and urinary disorders Renal failure chronic	0.40% 2/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Renal and urinary disorders Renal failure acute	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Gastrointestinal disorders Diverticulum intestinal	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Gastrointestinal disorders Dysphagia	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Gastrointestinal disorders Rectal haemorrhage	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Metabolism and nutrition disorders Decreased appetite	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Metabolism and nutrition disorders Fluid intake reduced	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Metabolism and nutrition disorders Fluid retention	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm malignant	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Surgical and medical procedures Knee arthroplasty	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Surgical and medical procedures Stent placement	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Blood and lymphatic system disorders Anaemia	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Nervous system disorders Extrapyramidal disorder	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Psychiatric disorders Confusional state	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.
Vascular disorders Cerebral microangiopathy	0.20% 1/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.

Other adverse events

Measure	Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism n=500 participants at risk Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
Renal and urinary disorders Chronic Kidney Failure	33.6% 168/500 • All adverse events were collected during the study up to 12 months. Serious adverse events were collected up to 30 days after the end of study.

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