Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

Conditions
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Secondary Hyperparathyroidism, Hemodialysis

Intervention / Treatment
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* Drug: Paricalcitol


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paricalcitol 2 µg ± 1 µg<br>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. | Drug: Paricalcitol<br>* Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.<br>* Other names: Zemplar;|
| Experimental: Paricalcitol 2 µg ± 2 µg<br>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. | Drug: Paricalcitol<br>* Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.<br>* Other names: Zemplar;|
| Experimental: Paricalcitol 4 µg ± 1 µg<br>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. | Drug: Paricalcitol<br>* Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.<br>* Other names: Zemplar;|
| Experimental: Paricalcitol 4 µg ± 2 µg<br>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. | Drug: Paricalcitol<br>* Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.<br>* Other names: Zemplar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants With of Hypercalcemia | 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. | Anytime during the study through Week 53 | 
| The Percentage of Participants With Hyperphosphatemia | 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. | Anytime during the study through Week 53 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary hyperparathyroidism, Hemodialysis, paricalcitol