Interaction Between Rimonabant and Cyclosporine and Tacrolimus (RIMONA-PILOT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00525681|
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplantation||Drug: cyclosporine A Drug: tacrolimus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Rimonabant Treatment on Cardiovascular Risk Factors in Renal Transplant Recipients -- Pilot Safety Study|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
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
- Effect of rimonabant on cylosporine/tacrolimus bioavailablility [ Time Frame: 2 months ]
- Effect of rimonabant on insulin sensitivity [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525681
|Rikshospitalet, Section of Nephrology|
|Oslo, Norway, 0027|
|Study Chair:||Anders Åsberg, Ph.D.||Scholl of Pharmacy, University of Oslo|