Trial Outcomes & Findings for Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice (NCT NCT01083849)

Last Updated: 2014-12-19

Results Overview

Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).

Recruitment status

COMPLETED

Target enrollment

761 participants

Primary outcome timeframe

Up to 12 Months

Results posted on

2014-12-19

Participant Flow

761 participants were enrolled in the study, but two participants lacked information necessary for assignment to one of the analysis groups (pre-dialysis or dialysis). Hence, analysis was conducted with 759 participants.

Participant milestones

Participant milestones
Measure	Paricalcitol Pre-dialysis Group Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
Overall Study STARTED	121	638
Overall Study COMPLETED	61	527
Overall Study NOT COMPLETED	60	111

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paricalcitol Pre-dialysis Group n=121 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group n=638 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Total n=759 Participants Total of all reporting groups
Age, Continuous	64.2 years STANDARD_DEVIATION 13.9 • n=5 Participants	62.5 years STANDARD_DEVIATION 14.9 • n=7 Participants	62.8 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	291 Participants n=7 Participants	338 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	347 Participants n=7 Participants	421 Participants n=5 Participants
Duration of Chronic Kidney Disease	39.3 months STANDARD_DEVIATION 36.0 • n=5 Participants	71.2 months STANDARD_DEVIATION 61.1 • n=7 Participants	67.5 months STANDARD_DEVIATION 59.6 • n=5 Participants
Duration of Secondary Hyperparathyroidism	17.7 months STANDARD_DEVIATION 20.6 • n=5 Participants	43.9 months STANDARD_DEVIATION 36.6 • n=7 Participants	39.5 months STANDARD_DEVIATION 35.8 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 Months

Population: Participants with a determined chronic kidney disease (CKD) stage

Outcome measures

Outcome measures
Measure	Paricalcitol n=718 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months Stage 3 [N=56]	30.4 percentage of participants	—
Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months Stage 4 [N=82]	30.5 percentage of participants	—
Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months Stage 5 [N=580]	70.2 percentage of participants	—

PRIMARY outcome

Timeframe: Up to 12 months

Population: Participants with a determined chronic kidney disease (CKD) stage

Outcome measures

Outcome measures
Measure	Paricalcitol n=718 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months Stage 3 [N=17]	212.4 days Standard Deviation 203.93	—
Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months Stage 5 [N=407]	145.7 days Standard Deviation 107.1	—
Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months Stage 4 [N=25]	195.5 days Standard Deviation 118.3	—

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, and 12

Population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.

Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.

Outcome measures

Outcome measures
Measure	Paricalcitol n=96 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group n=637 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
Number of Participants With Hypercalcemia Month 0	1 participants	2 participants
Number of Participants With Hypercalcemia Month 3	2 participants	6 participants
Number of Participants With Hypercalcemia Month 6	1 participants	4 participants
Number of Participants With Hypercalcemia Month 9	1 participants	4 participants
Number of Participants With Hypercalcemia Month 12	1 participants	5 participants

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, and 12

Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.

Outcome measures

Outcome measures
Measure	Paricalcitol n=96 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group n=637 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
Number of Participants With Hyperphosphatemia Month 0	5 participants	192 participants
Number of Participants With Hyperphosphatemia Month 3	8 participants	153 participants
Number of Participants With Hyperphosphatemia Month 6	8 participants	151 participants
Number of Participants With Hyperphosphatemia Month 9	9 participants	133 participants
Number of Participants With Hyperphosphatemia Month 12	8 participants	128 participants

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, and 12

Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg\^2/dL\^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.

Outcome measures

Outcome measures
Measure	Paricalcitol n=96 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group n=637 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
Number of Participants With Elevated Calcium-Phosphorus Product Month 0	5 participants	102 participants
Number of Participants With Elevated Calcium-Phosphorus Product Month 3	6 participants	97 participants
Number of Participants With Elevated Calcium-Phosphorus Product Month 6	7 participants	101 participants
Number of Participants With Elevated Calcium-Phosphorus Product Month 9	6 participants	89 participants
Number of Participants With Elevated Calcium-Phosphorus Product Month 12	4 participants	78 participants

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, and 11

Outcome measures

Outcome measures
Measure	Paricalcitol n=96 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group n=637 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
Mean Duration of Hospitalization by Visit Month 0	1.3 days Standard Deviation 4.9	0.7 days Standard Deviation 4.0
Mean Duration of Hospitalization by Visit Month 3	1.8 days Standard Deviation 4.4	0.8 days Standard Deviation 3.5
Mean Duration of Hospitalization by Visit Month 6	2.9 days Standard Deviation 5.9	0.8 days Standard Deviation 4.3
Mean Duration of Hospitalization by Visit Month 9	0.0 days Standard Deviation 0.0	0.8 days Standard Deviation 3.5
Mean Duration of Hospitalization by Visit Month 11	0.9 days Standard Deviation 4.0	0.6 days Standard Deviation 3.9

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, and 11

Outcome measures

Outcome measures
Measure	Paricalcitol n=96 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group n=637 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
Mean Duration of Disability by Visit Month 0	0.0 days Standard Deviation 0.0	0.3 days Standard Deviation 3.0
Mean Duration of Disability by Visit Month 3	4.7 days Standard Deviation 8.1	0.2 days Standard Deviation 2.0
Mean Duration of Disability by Visit Month 6	0.0 days Standard Deviation 0.0	0.4 days Standard Deviation 3.5
Mean Duration of Disability by Visit Month 9	0.0 days Standard Deviation 0.0	0.4 days Standard Deviation 3.1
Mean Duration of Disability by Visit Month 11	0.3 days Standard Deviation 1.0	0.4 days Standard Deviation 3.2

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, and 12

Outcome measures

Outcome measures
Measure	Paricalcitol n=96 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group n=637 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
Mean Intact Parathormone (iPTH) Levels by Visit Month 3	26.95 pmol/L Standard Deviation 36.94	37.20 pmol/L Standard Deviation 28.35
Mean Intact Parathormone (iPTH) Levels by Visit Month 6	23.01 pmol/L Standard Deviation 27.32	37.18 pmol/L Standard Deviation 30.08
Mean Intact Parathormone (iPTH) Levels by Visit Month 9	27.85 pmol/L Standard Deviation 33.95	36.54 pmol/L Standard Deviation 29.42
Mean Intact Parathormone (iPTH) Levels by Visit Month 12	29.57 pmol/L Standard Deviation 31.28	38.24 pmol/L Standard Deviation 33.76
Mean Intact Parathormone (iPTH) Levels by Visit Month 0	29.65 pmol/L Standard Deviation 26.95	54.85 pmol/L Standard Deviation 29.51

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, and 12

Outcome measures

Outcome measures
Measure	Paricalcitol n=96 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group n=637 Participants Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
Mean Calcium-Phosphate Product Levels by Visit Month 0	3.32 mmol²/l² Standard Deviation 3.12	4.12 mmol²/l² Standard Deviation 1.29
Mean Calcium-Phosphate Product Levels by Visit Month 3	3.50 mmol²/l² Standard Deviation 1.46	4.30 mmol²/l² Standard Deviation 1.26
Mean Calcium-Phosphate Product Levels by Visit Month 6	3.62 mmol²/l² Standard Deviation 1.61	4.32 mmol²/l² Standard Deviation 1.22
Mean Calcium-Phosphate Product Levels by Visit Month 9	3.61 mmol²/l² Standard Deviation 1.37	4.25 mmol²/l² Standard Deviation 1.29
Mean Calcium-Phosphate Product Levels by Visit Month 12	3.48 mmol²/l² Standard Deviation 1.20	4.21 mmol²/l² Standard Deviation 1.31

Adverse Events

Paricalcitol Pre-dialysis Group

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Paricalcitol Dialysis Group

Serious events: 186 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

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

Serious adverse events
Measure	Paricalcitol Pre-dialysis Group n=96 participants at risk Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.	Paricalcitol Dialysis Group n=637 participants at risk Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
Renal and urinary disorders Renal impairment	1.0% 1/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.00% 0/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Reproductive system and breast disorders Adenomyosis	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Reproductive system and breast disorders Menorrhagia	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Blood and lymphatic system disorders Anaemia	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.31% 2/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Blood and lymphatic system disorders Haemorrhagic anaemia	2.1% 2/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.00% 0/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Acute myocardial infarction	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Angina pectoris	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Aortic valve disease mixed	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Aortic valve stenosis	1.0% 1/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.31% 2/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Arrhythmia	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.31% 2/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Atrial fibrillation	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Cardiac arrest	1.0% 1/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.47% 3/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Cardiac failure	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.78% 5/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Cardiac tamponade	1.0% 1/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.00% 0/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Cardiopulmonary failure	1.0% 1/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.00% 0/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Cardiovascular disorder	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Coronary artery disease	2.1% 2/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.47% 3/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Left ventricular dysfunction	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Left ventricular failure	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Mitral valve incompetence	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Myocardial infarction	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.63% 4/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Cardiac disorders Ventricular fibrillation	1.0% 1/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Eye disorders Amaurosis	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Eye disorders Cataract	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Eye disorders Optic ischaemic neuropathy	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Eye disorders Vitreous haemorrhage	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Anal haemorrhage	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.31% 2/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Diarrhoea	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.31% 2/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Diverticular hernia	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Enterocolitis	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Gastric ulcer	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Gastritis	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Gastritis haemorrhagic	1.0% 1/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.00% 0/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Gastrointestinal haemorrhage	3.1% 3/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.31% 2/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Haematochezia	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Ileus	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.31% 2/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/96 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).	0.16% 1/637 • Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded. Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).