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

This study has been completed.
Sponsor:
Information provided by:
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT00525681
First received: September 5, 2007
Last updated: June 9, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Renal Transplantation
Drug: cyclosporine A
Drug: tacrolimus
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Oslo School of Pharmacy:

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

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

Estimated Enrollment: 16
Study Start Date: September 2007
Study Completion Date: May 2008
Arms Assigned Interventions
CsA
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
Tac
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00525681

Locations
Norway
Rikshospitalet, Section of Nephrology
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Investigators
Study Chair: Anders Åsberg, Ph.D. Scholl of Pharmacy, University of Oslo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00525681     History of Changes
Other Study ID Numbers: RIMONA-PILOT
Study First Received: September 5, 2007
Last Updated: June 9, 2008
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo School of Pharmacy:
Obese
Calcineurine inhibitor
Pharmacokinetics
Interaction

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Rimonabant
Tacrolimus
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Dermatologic Agents
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014