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Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients

NCT01265615 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2015-06-09

Study results available
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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.

Conditions

  • Cardiorenal Syndrome
  • Chronic Allograft Nephropathy

Interventions

DRUG

Paricalcitol

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

DRUG

Calcitriol

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

DRUG

Cholecalciferol

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

DIETARY_SUPPLEMENT

Supplemental

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

Sponsors & Collaborators

  • Ural Institute of Cardiology

    collaborator OTHER

  • De Haar Research Foundation

    collaborator OTHER

  • Ural State Medical University

    lead OTHER

Principal Investigators

  • Alexander Kharlamov, M.D. · Ural Institute of Cardiology

  • Alexander Perrish, M.D. · Ural State Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-04-30
Completion
2010-09-30

Countries

  • Netherlands
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01265615 on ClinicalTrials.gov