Status:
COMPLETED
A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to o...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- in receipt of an initial cadaveric kidney transplant;
- in receipt of graft with biopsy;
- in receipt of a 'marginal' kidney transplant.
Exclusion
- in receipt of a second kidney transplant;
- in receipt of a multi-organ transplant or a double kidney transplant;
- malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix;
- replicating hepatitis B and/or C, or HIV positive serology.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00817687
Start Date
January 1 2009
End Date
January 1 2012
Last Update
July 9 2012
Active Locations (17)
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1
Besançon, France, 25030
2
Bordeaux, France, 33076
3
Caen, France, 14033
4
Clermont-Ferrand, France, 63000