Phase 4
N=120
Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients
Cardiorenal Syndrome · Chronic Allograft Nephropathy
Bottom Line
View on ClinicalTrials.gov: NCT01265615 ↗Enrolled (actual)
120
Serious AEs
36.7%
Results posted
Jun 2011
Primary outcome: Primary: CAD (Chronic Allograft Dysfunction) Degree — 1.24; 1.22; 1.43; 1.68 Scores on a Banff scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paricalcitol (Drug); Calcitriol (Drug); Cholecalciferol (Drug); Supplemental (Dietary_supplement)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Ural State Medical University
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CAD (Chronic Allograft Dysfunction) Degree |
1.24; 1.22; 1.43; 1.68 | <0.05 sig |
| SECONDARY Heart Failure (HF) |
1.8; 1.9; 1.9; 2.5 | <0.05 sig |
| SECONDARY GFR (Glomerular Filtration Rate) |
84; 81; 76; 54 | <0.05 sig |
| SECONDARY CAD (Chronic Allograft Dysfunction) Degree |
1.24; 1.22; 1.43; 1.68 | <0.05 sig |
| SECONDARY Serum Creatinine |
2.5; 2.5; 2.8; 4.1 | <0.05 sig |
| SECONDARY Number of Circulating SP (Side Population) Stem-Progenitor Cells |
7.6; 6.5; 5.7; 4.2 | <0.05 sig |
| SECONDARY VDR (Vitamin D Receptor) Expression in Myocardium |
801; 715; 654; 389 | <0.05 sig |
| SECONDARY VDR (Vitamin D Receptor) Expression in Kidney |
584; 599; 478; 333 | <0.05 sig |
| SECONDARY Systolic Blood Pressure |
143; 141; 147; 165 | <0.05 sig |
| SECONDARY Coronary Calcium Score |
530; 611; 524; 990 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age 40-75
- Male
- History of chronic kidney disease and cardiorenal syndrome
- Written informed consent
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01265615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.