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Interaction Between Rimonabant and Cyclosporine and Tacrolimus (RIMONA-PILOT)

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ClinicalTrials.gov Identifier: NCT00525681
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
University of Oslo School of Pharmacy

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: cyclosporine A Drug: tacrolimus Phase 4

Detailed Description:
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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Rimonabant Treatment on Cardiovascular Risk Factors in Renal Transplant Recipients -- Pilot Safety Study
Study Start Date : September 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: tacrolimus
Dosing of tacrolimus is given twice daily and individualized as per center practice.
Other Name: Prograf

Primary Outcome Measures :
  1. Effect of rimonabant on cylosporine/tacrolimus bioavailablility [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Effect of rimonabant on insulin sensitivity [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Renal transplant recipient with stable renal function (less than 20% deviation in serum creatinine the last 2 months).
  • Renal transplant recipient currently on CsA or Tac and prednisolone based immunosuppression.
  • BMI > 30 kg/m2 or >27 kg/m2 in combination with one or more cardio-vascular risk factors.
  • > 18 years of age.
  • Male patient, or female patient without childbearing potential (surgically sterilized or postmenopausal) or, if female of childbearing potential, is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 Days following discontinuation of the Study Drugs.
  • Signed informed consent.

Exclusion Criteria:

  • Diabetes mellitus
  • Severe liver disease.
  • Depressive-, anxiety- or sleeping disorders.
  • Estimated GFR < 25 ml/min.
  • Epilepsy.
  • Skin disorders that may influence laser Doppler flowmetry investigations.
  • Pregnant or nursing mothers.
  • Concomitant treatment with CYP3A4 inhibitors (www.cyp450.no) with interaction potential according to the investigator.

Information from the National Library of Medicine

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
Sponsors and Collaborators
University of Oslo School of Pharmacy
Study Chair: Anders Åsberg, Ph.D. Scholl of Pharmacy, University of Oslo

Responsible Party: University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier: NCT00525681     History of Changes
Other Study ID Numbers: RIMONA-PILOT
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by University of Oslo School of Pharmacy:
Calcineurine inhibitor

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Hormones, Hormone Substitutes, and Hormone Antagonists