Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associa… (NCT00811915) | Clinical Trial Compass
TerminatedPhase 3
Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation
Stopped: Difficulty in enrolling new patients
France65 participantsStarted 2009-01
Plain-language summary
The use of tacrolimus in the long term as part of the immunosuppressive regimen after transplantation is associated to complications such as chronic nephrotoxicity, impaired glucose metabolism (diabetes mellitus) and an increase of the incidence of neoplasia. The conversion from a tacrolimus based therapy to a sirolimus based therapy associated with mycophenolate mofetil could improve the incidence of such complications. The aim of this study is to assess the risk/benefit ratio of this switch performed in stable renal transplant recipient between 12 months and 36 months after transplantation. The incidence of a composite endpoint (worsening of GFR evaluated by MDRD formula, incidence of cancer and diabetes) will be assessed 24 months after conversion.
Who can participate
Age range
18 Years – 76 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Recipient age ≥18 and ≤ 75 ans.
* Patients having received a first or second renal transplant from a cadaveric or living related donor between 12 and 24 months prior the inclusion.
* Peak panel reactive antibody (PRA) \< 30 %
* Patients with a stable renal function during the 3 months prior to inclusion (variation of serum creatinine lower than 20 %)
* Creatinine clearance ≥ 40 ml/mn/1.73 m26.
* Patients receiving as a stable immunosuppressive treatment associating: Mycophenolate mofetil (MPA AUC \> 30 mg.h/L) and Tacrolimus with a trough level \> 4 ng/ml, with or without corticoids
Exclusion Criteria:
* Multiorgan recipients
* Patients receiving cyclosporine
* Pregnancy
* Recipients of ABO incompatible graft
* Use of other immunosuppressive drugs.
* Historical peak reactive antibody ≥ 30 %
* Past medical history of humoral rejection, 2 episodes of acute cellular rejection
* Past medical history of sub-clinical rejection on routine allograft biopsy
* Calculated creatinine clearance \< 40 ml/mn/1.73 m2
* 24h proteinuria \> 1 g/24H
* Patients with severe diarrhea
* HTLV1 or HIV positivity
* Known hypersensitivity to tacrolimus, mycophenolate mofetil, or sirolimus.
* Total white blood cells \< 2500/mm3 or hemoglobin \< 9 g/dl
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of a composite endpoint (worsening of GFR estimated with MDRD formula, incidence of cancer and incidence of post-transplant diabetes mellitus) will be assessed 24 months after conversion.