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

This study has been completed.
Sponsor:
Collaborator:
Ural Institute of Cardiology
Information provided by:
Ural State Medical Academy
ClinicalTrials.gov Identifier:
NCT01265615
First received: December 22, 2010
Last updated: May 23, 2011
Last verified: November 2010
History of Changes
Results First Received: December 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Cardiorenal Syndrome
Chronic Allograft Nephropathy
Interventions: Drug: Paricalcitol
Drug: Calcitriol
Drug: Cholecalciferol
Dietary Supplement: Supplemental

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 120 patients (Russian and dutch caucasian, kidney recipients with vitamin D deficiency defined as 25(OH)D < 30 ng/mL) were assigned on the basis of Ural Institute of Cardiology. Nine of the 120 patients were subsequently excluded due to protocol violation. All the patients had given their written informed consents.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Paricalcitol Treatment 6-8 μg daily per os without special diet
Calcitriol Treatment 2-4 μg daily orally under with dietary restrictions of vitamin D
Cholecalciferol alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
Supplemental intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day

Participant Flow:   Overall Study
    Paricalcitol Treatment     Calcitriol Treatment     Cholecalciferol     Supplemental  
STARTED     30     30     30     30  
COMPLETED     28     28     26     27  
NOT COMPLETED     2     2     4     3  
Protocol Violation                 2                 2                 4                 3  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   CAD (Chronic Allograft Dysfunction) Degree   [ Time Frame: day 180 after Tx (transplantation) ]
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2.  Secondary:   Heart Failure (HF)   [ Time Frame: on day 180 after Tx (transplantation) ]
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3.  Secondary:   GFR (Glomerular Filtration Rate)   [ Time Frame: on day 180 ]
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4.  Secondary:   CAD (Chronic Allograft Dysfunction) Degree   [ Time Frame: on day 90 ]
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5.  Secondary:   Serum Creatinine   [ Time Frame: on day 180 after Tx ]
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6.  Secondary:   Number of Circulating SP (Side Population) Stem-Progenitor Cells   [ Time Frame: on day 180 ]
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7.  Secondary:   VDR (Vitamin D Receptor) Expression in Myocardium   [ Time Frame: on day 180 ]
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8.  Secondary:   VDR (Vitamin D Receptor) Expression in Kidney   [ Time Frame: on day 180 ]
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9.  Secondary:   Systolic Blood Pressure   [ Time Frame: on day 180 ]
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10.  Secondary:   Coronary Calcium Score   [ Time Frame: on day 180 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Alexander Kharlamov
Organization: Ural Institute of Cardiology, Ural State Medical Academy
phone: +79638547663
e-mail: drskharlamov@gmail.com


No publications provided


Responsible Party: Jan Gabinsky/ Prof. Dr., C.E.O., Ural Institute of Cardiology
ClinicalTrials.gov Identifier: NCT01265615     History of Changes
Other Study ID Numbers: VDCRS03
Study First Received: December 22, 2010
Results First Received: December 27, 2010
Last Updated: May 23, 2011
Health Authority: Russia: Ethics Committee