Status:
COMPLETED
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
Lead Sponsor:
University Hospital, Rouen
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-76 years
Phase:
PHASE3
Brief 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 (diabet...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00811915
Start Date
January 1 2009
End Date
June 1 2014
Last Update
June 19 2014
Active Locations (8)
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1
UHAmiens
Amiens, France
2
UHAngers
Angers, France, 49933
3
UHCaen
Caen, France, 14000
4
UHLimoges
Limoges, France