NCT00823303

Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Secondary Hyperparathyroidism
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Paricalcitol	1 mcg daily, adjusted to achieve 40-60% PTH suppression
DRUG	Calcitriol	0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-05-01
• Completion: 2013-09-01
• First posted: 2009-01-15
• Last updated: 2014-08-07
• Results posted: 2014-08-05

Locations

4 sites across 1 country: United States