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Interaction Between Rimonabant and Cyclosporine and Tacrolimus

NCT00525681 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-12-03

No results posted yet for this study

Summary

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.

Conditions

  • Renal Transplantation

Interventions

DRUG

cyclosporine A

Cyclosporine is dosed twice daily and is individualized as per center practice and kept stable during the study.

DRUG

tacrolimus

Dosing of tacrolimus is given twice daily and individualized as per center practice.

Sponsors & Collaborators

  • University of Oslo School of Pharmacy

    lead OTHER

Principal Investigators

  • Anders Åsberg, Ph.D. · Scholl of Pharmacy, University of Oslo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525681 on ClinicalTrials.gov