Phase 2
Completed N=104
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
Source: ClinicalTrials.gov NCT00701805 ↗Enrolled (actual)
104
Serious AEs
22.6%
Results posted
Apr 2011
Primary outcomePrimary: The Percentage of Participants With of Hypercalcemia — 40.74; 63.33; 60.87; 65.38 Percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With of Hypercalcemia |
40.74; 63.33; 60.87; 65.38 | — |
| PRIMARY The Percentage of Participants With Hyperphosphatemia |
40.74; 36.67; 26.09; 38.46 | — |
| SECONDARY The Mean Change in Intact Parathyroid Hormone (iPTH) |
-263.7; -223.3; -248.3; -173.3 | — |
| SECONDARY The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit |
42.3; 41.4; 39.1; 38.5; 57.7; 51.7 | — |
| SECONDARY The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% |
100.0; 100.0; 100.0; 96.2 | — |
| SECONDARY Change in Mean iPTH |
517.7; 502.5; 510.9; 519.7; 543.5; 548.2 | — |
| SECONDARY Duration of 2 Consecutive Decreases in iPTH >= 50% |
60.6; 38.8; 47.2; 30.2 | — |
| SECONDARY Duration of 2 Consecutive iPTH Values <= 180 pg/mL |
35.1; 29.2; 28.2; 20.7 | — |
| SECONDARY The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit |
66.7; 50.0; 50.0; 42.9 | — |
| SECONDARY The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit |
50.0; 80.0; 50.0; 72.7 | — |
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).
Data sourced from ClinicalTrials.gov (NCT00701805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.