NCT00525681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

September 5, 2007

Last Update Submit

December 2, 2014

Conditions

Renal Transplantation

Keywords

ObeseCalcineurine inhibitorPharmacokineticsInteraction

Outcome Measures

Primary Outcomes (1)

  • Effect of rimonabant on cylosporine/tacrolimus bioavailablility

    2 months

Secondary Outcomes (1)

  • Effect of rimonabant on insulin sensitivity

    2 months

Study Arms (2)

CsA

OTHER

Investigation of systemic exposure of cyclosporine before and after 2 moths of co-adminiastration of rimonabant.

Drug: cyclosporine A

Tac

OTHER

Investigation of systemic exposure of tacrolimus before and after 2 moths of co-adminiastration of rimonabant.

Drug: tacrolimus

Interventions

cyclosporine ADRUG

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

Also known as: Sandimmun Neoral
CsA
tacrolimusDRUG

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

Also known as: Prograf
Tac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet, Section of Nephrology

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Obesity

Interventions

CyclosporineTacrolimus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Anders Åsberg, Ph.D.

    Scholl of Pharmacy, University of Oslo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 6, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

NO(1)