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Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.
Details
| Lead sponsor | AbbVie (prior sponsor, Abbott) |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 255 |
| Start date | 2011-05 |
| Completion | 2012-04 |
Conditions
- Secondary Hyperparathyroidism
- Hemodialysis
Interventions
- paricalcitol
- maxacalcitol
- paricalcitol placebo
- maxacalcitol placebo
Primary outcomes
- Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia — iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).
The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value \> 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
Countries
Japan