Interaction Between Rimonabant and Cyclosporine and Tacrolimus (RIMONA-PILOT)
The major cause of premature death in renal transplant recipients is cardio-vascular disease. In addition, obesity is becoming a major problem in this patient population. Rimonabant does not only seem to have weight reducing properties but also weight reduction independent effects on insulin sensitivity and endothelial function, two important cardio-vascular risk factors. Rimonabant therefore is an interesting drug for the treatment of transplanted patients. Present data also indicate that rimonabant does not interact with essential immunosuppressive drugs (CsA and Tac) indicating that it most probably is safe to administer to this patient population. However this needs to be investigated in a proper manner.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Rimonabant Treatment on Cardiovascular Risk Factors in Renal Transplant Recipients -- Pilot Safety Study|
- Effect of rimonabant on cylosporine/tacrolimus bioavailablility [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Effect of rimonabant on insulin sensitivity [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Investigation of systemic exposure of cyclosporine before and after 2 moths of co-adminiastration of rimonabant.
Drug: cyclosporine A
Cyclosporine is dosed twice daily and is individualized as per center practice and kept stable during the study.
Other Name: Sandimmun Neoral
Investigation of systemic exposure of tacrolimus before and after 2 moths of co-adminiastration of rimonabant.
Dosing of tacrolimus is given twice daily and individualized as per center practice.
Other Name: Prograf
Renal transplant recipients are treated with life-long immunosuppressive therapy in order to prevent acute rejection episodes. The calcineurin inhibitors (CsA and Tac) are the back-bones in the immunosuppressive treatment and they have a very narrow therapeutic index. It is therefore essential to assure that new drug to be used in transplanted patients do not interact with CsA and Tac. Even though rimonabant is metabolized via the same enzyme as CsA and Tac (CYP3A4) previous in vitro and in vivo studies with relevant probe drugs in healthy volunteers do not indicate the presence of any relevant pharmacokinetic interaction. However, to be absolutely sure that it is safe to administer rimonabant in transplanted patients a 12-hour pharmacokinetic interaction investigation is included for 16 patients in the present pilot study (8 patients on CsA and 8 patients on Tac).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525681
|Rikshospitalet, Section of Nephrology|
|Oslo, Norway, 0027|
|Study Chair:||Anders Åsberg, Ph.D.||Scholl of Pharmacy, University of Oslo|