Status:
COMPLETED
A Study of Mycophenolate Mofetil and Cyclosporin, Without Concomitant Corticosteroids, After a First Renal Transplant
Lead Sponsor:
Nantes University Hospital
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The trial is planned as a multicentric, randomized, prospective, open study in accordance with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with chronic renal insuff...
Eligibility Criteria
Inclusion
- Patient who is a candidate for a first cadaver renal transplantation and included on the national list of the Etablissement Français des Greffes
- Man or woman aged between 18 and 65 years
- Women of reproductive age must agree to use a reliable contraceptive method throughout the first year of the study
- Donor aged between 18 and 65 years
- Patient who has been given full information about the study and who has given his written informed consent to take part in it.
Exclusion
- Women who are pregnant or breast-feeding
- Patient with an immunological risk considered high and defined as a percentage of anti-HLA antibodies of ³20% (previous or recent determination of T lymphocytes)
- Patient with a history of allergy to rabbit proteins
- Cold ischaemia time of more than 36 hours
- Patient allergic to macrolide antibiotics, to tacrolimus or to MMF
- Patient on immunosuppressant treatment before transplantation
- Patient suffering from a malignant neoplasm or with a history of malignant neoplasia, with the exception of treated baso- or spinocellular cancers
- Patient waiting for another transplant in addition to the kidney
- Patient who has already received an organ or tissue graft
- Leukocyte count \<2000/mm3 and/or platelet count \<50 000/mm3
- Patient suffering from focal glomerulonephritis
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00200551
Start Date
January 1 2001
End Date
April 1 2010
Last Update
February 5 2013
Active Locations (5)
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1
Besançon Universitary Hospital
France, Besançon, France, 25030
2
Montpellier Universitary Hospital
Montpellier, France, 34059
3
Nantes University Hospital
Nantes, France, 44093
4
Nice Universitary Hospital
Nice, France, 06202