Chronic Kidney Disease Clinical Trial
Official title:
A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.
General Design
- Open label, active comparator, multicenter, parallel group, phase 4 study of
paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients
with SHPT.
- Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week
follow up.
- Patients meeting inclusion/exclusion criteria including baseline laboratory results
will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase.
Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18,
and 24. A follow up visit will be performed 1 week after stopping study medication.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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