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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Two doses of Sirolimus will be evaluated accorded to the CYP 3A5 genotype. Patients carrying at least CYP 3A5 \*1 allele will receive 4 mg per day whereas the others (CYP 3A5 \*3/\*3) will receive 2 mg.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sirolimus

Group A : Sirolimus introduction and tacrolimus withdrawal

* Tacrolimus : 33 % decrease of daily dose with complete withdrawal at day 14.
* Sirolimus daily dose according to CYP3A5 genotype CYP3A5\*1/\*1 or \*1/\*3: 4 mg/d CYPY3A5\*3/\*3 : sirolimus 2 mg/j Adjusted to obtain a trough level between 6 and10 ng/ml

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

Sirolimus introduction and tacrolimus withdrawal

Tacrolimus : 33 % decrease of daily dose with complete withdrawal at day 14. Sirolimus daily dose according to CYP3A5 genotype CYP3A5\*1/\*1 or \*1/\*3: 4 mg/d CYPY3A5\*3/\*3 : sirolimus 2 mg/j Adjusted to obtain a trough level between 6 and10 ng/ml

B

Tacrolimus (Advagraf) dose to obtain a trough level between 4 and 10 ng/ml

Group Type ACTIVE_COMPARATOR

Sirolimus

Intervention Type DRUG

Sirolimus introduction and tacrolimus withdrawal

Tacrolimus : 33 % decrease of daily dose with complete withdrawal at day 14. Sirolimus daily dose according to CYP3A5 genotype CYP3A5\*1/\*1 or \*1/\*3: 4 mg/d CYPY3A5\*3/\*3 : sirolimus 2 mg/j Adjusted to obtain a trough level between 6 and10 ng/ml

Interventions

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Sirolimus

Sirolimus introduction and tacrolimus withdrawal

Tacrolimus : 33 % decrease of daily dose with complete withdrawal at day 14. Sirolimus daily dose according to CYP3A5 genotype CYP3A5\*1/\*1 or \*1/\*3: 4 mg/d CYPY3A5\*3/\*3 : sirolimus 2 mg/j Adjusted to obtain a trough level between 6 and10 ng/ml

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No