CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 110 enrolled
Drug / intervention
Paricalcitol +1 moredrug
Likely dose
Paricalcitol 1 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00823303
NCT00823303Phase 4Completed
CompareCT.gov

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

Washington University School of Medicine·interventional·Posted Jan 15, 2009·Updated Aug 7, 2014

In Brief

A Phase 4 clinical trial evaluating Paricalcitol and Calcitriol for Secondary Hyperparathyroidism and Chronic Kidney Disease. Completed, enrolled 110 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism, Chronic Kidney Disease
CountriesUnited States
CollaboratorsHenry Ford Hospital, Northwestern University, Endeavor Health, Abbott

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMay 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.5 years ago

Interventions

Paricalcitoldrug

1 mcg daily, adjusted to achieve 40-60% PTH suppression

Calcitrioldrug

0.25 mcg daily, adjusted to achieve 40-60% PTH suppression