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

Phase 4

Completed

• Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism
• Interventions: Drug: Paricalcitol; Drug: Calcitriol

• Registration Number: NCT00823303
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Study Start: 2009-02
• Primary Completion: 2013-05
• Study Completion: 2013-09
• Results First Submitted: 2014-06-05
• Results First Submitted QC: 2014-07-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Results First Posted: 2014-08-05
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paricalcitol	Paricalcitol	titrated to achieve 40-60% PTH suppression
Calcitriol	Calcitriol	titrated to achieve 40-60% PTH suppression

Primary Outcome Measures

Name	Time	Method
Confirmed Hypercalcemia	24 week treatment period	Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.

Trial Locations

Locations (4)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Northshore University Health System; 🇺🇸 Evanston, Illinois, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States