Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients
Phase 4 Study of Paricalcitol and Calcitriol for Reparative Management of Chronic Allograft Dysfunction and Renocardiac Syndrome in Vitamin D Insufficient Renal Transplant Recipients
1 other identifier
interventional
109
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2009
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 22, 2010
CompletedFirst Posted
Study publicly available on registry
December 23, 2010
CompletedResults Posted
Study results publicly available
June 21, 2011
CompletedJune 9, 2015
May 1, 2015
6 months
December 22, 2010
December 27, 2010
May 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CAD (Chronic Allograft Dysfunction) Degree
Beyond 180 days, chronic allograft dysfunction (CAD) was characterized by mean Banff degree (revised 2005/2007 criteria) with the data of renal biopsy material. Renal tissue was recovered during routined biopsy. We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades: Grade I. Mild interstitial fibrosis and tubular atrophy (\<25% of cortical area) II. Moderate (26-50%) III. Severe (\>50%) (may include non-specific vascular and glomerular sclerosis)
day 180 after Tx (transplantation)
Secondary Outcomes (9)
Heart Failure (HF)
on day 180 after Tx (transplantation)
GFR (Glomerular Filtration Rate)
on day 180
CAD (Chronic Allograft Dysfunction) Degree
on day 90
Serum Creatinine
on day 180 after Tx
Number of Circulating SP (Side Population) Stem-Progenitor Cells
on day 180
- +4 more secondary outcomes
Study Arms (4)
Paricalcitol treatment
ACTIVE COMPARATOR6-8 μg daily per os (orally) without special diet
Calcitriol treatment
ACTIVE COMPARATOR2-4 μg daily orally under with dietary restrictions of vitamin D
Cholecalciferol
ACTIVE COMPARATORalendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
Supplemental
OTHERintake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Interventions
paricalcitol group (6-8 μg daily per os - orally - without special diet)
calcitriol group (2-4 μg daily orally under with dietary restrictions of vitamin D)
cholecalciferol group (intake of cholecalciferol with recommended daily allowance equals 1200-2400 IU per day)
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Eligibility Criteria
You may qualify if:
- Age 40-75
- Male
- History of chronic kidney disease and cardiorenal syndrome
- Written informed consent
You may not qualify if:
- Female
- Acute illness
- Life-threat competitive illness
- Mental disorders
- Endocrinologic diseases (including diabetes mellitus, hyperparathyroidism, and other thyroid disorders)
- Need for dialyses
- Hypercalcemia
- Concomitant use of hormone or cytokine medication
- Participation to any drug-investigation during the previous 60 days as checked with VIP check
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ural State Medical Universitylead
- Ural Institute of Cardiologycollaborator
- De Haar Research Foundationcollaborator
Study Sites (2)
De Haar Research Foundation
Rotterdam, South Holland, 3071PR, Netherlands
Ural Institute of Cardiology
Yekaterinburg, 620144, Russia
Related Publications (1)
Kharlamov AN, Perrish AN, Gabiskii IaL, Ronne Kh, Ivanova EIu. [Vitamin D in the treatment of cardiorenal syndrome in patients with chronic nephropathy]. Kardiologiia. 2012;52(3):33-44. Russian.
PMID: 22839442RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Alexander Kharlamov
- Organization
- Ural Institute of Cardiology, Ural State Medical Academy
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Kharlamov, M.D.
Ural Institute of Cardiology
- PRINCIPAL INVESTIGATOR
Alexander Perrish, M.D.
Ural State Medical University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer at the Ural Medical University
Study Record Dates
First Submitted
December 22, 2010
First Posted
December 23, 2010
Study Start
October 1, 2009
Primary Completion
April 1, 2010
Study Completion
September 1, 2010
Last Updated
June 9, 2015
Results First Posted
June 21, 2011
Record last verified: 2015-05