Renal TransplantationPhase 4RIMONA-PILOTNCT00525681
Interaction Between Rimonabant and Cyclosporine and Tacrolimus
A Phase 4 study testing cyclosporine A and tacrolimus in people with Renal Transplantation, run by University of Oslo School of Pharmacy at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- cyclosporine A and tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2007to May 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Rimonabant Treatment on Cardiovascular Risk Factors in Renal Transplant Recipients -- Pilot Safety Study
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.
Read the 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).
- Conditions
- Renal Transplantation
- Being tested
- cyclosporine A, tacrolimus
- Keywords
- Obese, Calcineurine inhibitor, Pharmacokinetics, Interaction
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporine ADrug
Also called Sandimmun Neoral
Cyclosporine is dosed twice daily and is individualized as per center practice and kept stable during the study.
tacrolimusDrug
Also called Prograf
Dosing of tacrolimus is given twice daily and individualized as per center practice.
| Study group | Role | What they receive |
|---|---|---|
| CsA | Other | Investigation of systemic exposure of cyclosporine before and after 2 moths of co-adminiastration of rimonabant. Receives: Drug: cyclosporine A |
| Tac | Other | Investigation of systemic exposure of tacrolimus before and after 2 moths of co-adminiastration of rimonabant. Receives: Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of rimonabant on cylosporine/tacrolimus bioavailablility
Measured: 2 months
Secondary outcomes (1)
Effect of rimonabant on insulin sensitivity
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo School of Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Åsberg, Ph.D., Study chair, Scholl of Pharmacy, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525681
- Sponsor's protocol ID
- RIMONA-PILOT
- Acronym
- RIMONA-PILOT
- Status last verified
- Dec 2014
- First submitted
- 5 Sep 2007
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rimonabant Treatment on Cardiovascular Risk Factors in Renal Transplant Recipients -- Pilot Safety Study
- ClinicalTrials.gov ID
- NCT00525681
- Acronym / sponsor ID
- RIMONA-PILOT / RIMONA-PILOT
- Conditions
- Renal Transplantation
- Keywords
- Obese, Calcineurine inhibitor, Pharmacokinetics, Interaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Oslo School of PharmacyUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CsA | Other | Drug: cyclosporine AInvestigation of systemic exposure of cyclosporine before and after 2 moths of co-adminiastration of rimonabant. |
| Tac | Other | Drug: tacrolimusInvestigation of systemic exposure of tacrolimus before and after 2 moths of co-adminiastration of rimonabant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Diabetes mellitus
- Severe liver disease.
- Depressive-, anxiety- or sleeping disorders.
- Estimated GFR < 25 ml/min.
- Epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyclosporine AAlso: Sandimmun NeoralCyclosporine is dosed twice daily and is individualized as per center practice and kept stable during the study. | Drug | CsA |
| tacrolimusAlso: PrografDosing of tacrolimus is given twice daily and individualized as per center practice. | Drug | Tac |
Primary outcome
Effect of rimonabant on cylosporine/tacrolimus bioavailablility
Time frame: 2 months
1 secondary outcome
Effect of rimonabant on insulin sensitivity
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Åsberg, Ph.D. study chair
Scholl of Pharmacy, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cyclosporine A and tacrolimus in people with Renal Transplantation, run by University of Oslo School of Pharmacy at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of rimonabant on cylosporine/tacrolimus bioavailablility (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.