CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 109 enrolled
Drug / intervention
Paricalcitol +3 moredrug
Likely dose
Paricalcitol 8 μgfrom 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/NCT01265615
NCT01265615Phase 4Completed
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Phase 4 Study of Paricalcitol and Calcitriol for Reparative Management of Chronic Allograft Dysfunction and Renocardiac Syndrome in Vitamin D Insufficient Renal Transplant Recipients

Ural State Medical University·interventional·Posted Dec 23, 2010·Updated Jun 9, 2015

In Brief

A Phase 4 clinical trial evaluating Paricalcitol, Calcitriol, and 2 other interventions for Cardiorenal Syndrome and Chronic Allograft Nephropathy. Completed, enrolled 109 participants across 2 sites in 2 countries.

Detailed Summary

We hypothesize that paricalcitol and calcitriol in dose-dependent manner are effective for the management of chronic allograft dysfunction (CAD), protection and repair of kidney and heart, management of chronic renocardiac syndrome (CRS). We assume that paricalcitol can have some advantages if compare with calcitriol or cholecalciferol due to absence of calcemic and phosphatemic complications alongside with great beneficial potential.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiorenal Syndrome, Chronic Allograft Nephropathy
CountriesNetherlands, Russia
CollaboratorsUral Institute of Cardiology, De Haar Research Foundation

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2010
Enrollment StartOct 1, 2009
Primary CompletionApr 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.5 years ago

Interventions

Paricalcitoldrug

paricalcitol group (6-8 μg daily per os - orally - without special diet)

Calcitrioldrug

calcitriol group (2-4 μg daily orally under with dietary restrictions of vitamin D)

Cholecalciferoldrug

cholecalciferol group (intake of cholecalciferol with recommended daily allowance equals 1200-2400 IU per day)

Supplementaldietary

intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day