Status:
COMPLETED
Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation
Lead Sponsor:
Poitiers University Hospital
Conditions:
Kidney Transplantation
Eligibility:
All Genders
25+ years
Phase:
PHASE3
Brief Summary
We have previously defined factors that predict the long term success of maintenance CsA monotherapy (CsAm) after kidney transplantation : donor age \< 40 years, serum creatinine level at the initiati...
Detailed Description
Between july 1998 and january 2004 selected patients were randomly assigned equally within each centre to receive CsAm or bitherapy with equally CsA + MMF or CsA + AZA.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Primary cadaveric renal transplant with induction therapy, delayed Neoral, MMF and prednisone
- Steroid withdrawal \>= 3 months before enrolment
- Bitherapy Neoral + CellCept
- Follow up time since transplantation : 11-24 months
- Recipient age \>= 25 years
- Donor age \<= 45 years
- Serum creatinine level \<= 125 µmol/L and/or calculated creatinine clearance \>= 50 ml/mn (CG formula)
- No or only one steroid-sensitive acute rejection episode during the first year post-transplantation
- PRA \<= 25 %
- Written informed consent
- Exclusion Criteria:
- Living donor transplantation
- Recipient receiving tacrolimus
- Azathioprine intolerance
- Thrombopenia \< 100 000/mm³
- Neutropenia \< 1500/mm³
- Hemoglobinemia \<= 8g/dl
- On going infection
Exclusion
Key Trial Info
Start Date :
July 1 1998
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00461825
Start Date
July 1 1998
End Date
February 1 2007
Last Update
April 18 2007
Active Locations (5)
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1
Caen university Hospital
Caen, France, 14033
2
Dupuytren University Hospital
Limoges, France, 87042
3
Poitiers University hospital
Poitiers, France, 86021
4
Reims University Hospital
Reims, France, 51092