Trial Outcomes & Findings for Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose (NCT NCT00891813)

Last Updated: 2011-10-31

Results Overview

The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

24 weeks

Results posted on

2011-10-31

Participant Flow

A total of 114 participants were screened. Of those, 100 participants were enrolled and received at least one dose of study drug.

Participant milestones

Participant milestones
Measure	Paricalcitol Injection Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
Overall Study STARTED	100
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Paricalcitol Injection Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	1
Overall Study Patient Noncompliance	6
Overall Study Protocol Violation	2

Baseline Characteristics

Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paricalcitol Injection n=100 Participants Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
Age Continuous	46 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Region of Enrollment Peru	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Analysis is based on the number of participants completing the study.

Outcome measures

Outcome measures
Measure	Paricalcitol Injection n=88 Participants Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL	96.6 Percentage of participants

SECONDARY outcome

Timeframe: 24 Weeks

Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.

Outcome measures

Outcome measures
Measure	Paricalcitol Injection n=100 Participants Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL	4 Weeks Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: 24 Weeks

The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter \[mg/dL\]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.

Outcome measures

Outcome measures
Measure	Paricalcitol Injection n=100 Participants Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). Hypercalcemia	38 Number of participants
Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). Hyperphosphatemia	33 Number of participants
Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). Elevation of Ca x P product	31 Number of participants

Adverse Events

Paricalcitol Injection

Serious events: 15 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paricalcitol Injection n=100 participants at risk Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
Cardiac disorders Acute coronary syndrome	1.0% 1/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Cardiac disorders Atrioventricular block complete	1.0% 1/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Cardiac disorders Bradycardia	1.0% 1/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	1.0% 1/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.0% 1/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
General disorders Pyrexia	2.0% 2/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Infections and infestations Cellulitis	2.0% 2/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Infections and infestations Pneumonia	5.0% 5/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Injury, poisoning and procedural complications Humerus fracture	1.0% 1/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.0% 1/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Nervous system disorders Cerebrovascular accident	1.0% 1/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	4.0% 4/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.

Other adverse events

Other adverse events
Measure	Paricalcitol Injection n=100 participants at risk Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
Metabolism and nutrition disorders Hypercalcemia	32.0% 32/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
Metabolism and nutrition disorders Hyperphosphatemia	24.0% 24/100 • Baseline through 24 weeks. The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.

Additional Information

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Principal investigator is a sponsor employee Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
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