Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Overview
- Phase
- Phase 2
- Intervention
- Paricalcitol
- Conditions
- Hemodialysis
- Sponsor
- Abbott
- Enrollment
- 107
- Primary Endpoint
- The Percentage of Participants With of Hypercalcemia
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).
Detailed Description
The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who completed 12 weeks of Study M10-309 (NCT00667576).
Exclusion Criteria
- •Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism.
- •Patients with progressive malignancy or clinically significant hepatic disease.
- •Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
- •Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
Arms & Interventions
Paricalcitol 2 µg ± 1 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Intervention: Paricalcitol
Paricalcitol 2 µg ± 2 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Intervention: Paricalcitol
Paricalcitol 4 µg ± 1 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Intervention: Paricalcitol
Paricalcitol 4 µg ± 2 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Intervention: Paricalcitol
Outcomes
Primary Outcomes
The Percentage of Participants With of Hypercalcemia
Time Frame: Anytime during the study through Week 53
The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during the 52 weeks of the study.
The Percentage of Participants With Hyperphosphatemia
Time Frame: Anytime during the study through Week 53
The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus \>= 7.0 mg/dL during the 52 weeks of the study.
Secondary Outcomes
- The Mean Change in Intact Parathyroid Hormone (iPTH)(From Baseline to Final Visit (which could occur anytime between study initiation and Week 53))
- The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit(From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53))
- The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%(Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53))
- Change in Mean iPTH(Every week from Baseline through Week 13 and every other week thereafter until Week 53)
- Duration of 2 Consecutive Decreases in iPTH >= 50%(From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53))
- Duration of 2 Consecutive iPTH Values <= 180 pg/mL(From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53))
- The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit(From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53))
- The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit(From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53))