A randomized, prospective, multicenter trial to compare the effect on chronic allograft nephropathy prevention of mycophenolate mofetil versus azathioprine as the sole immunosuppressive therapy for kidney transplant recipients - MAMMOUTH

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 sites224 target enrollmentJanuary 5, 2007

Overview

No summary available.

Registry

who.int

Start Date

January 5, 2007

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IST. DI RICERCHE FARMACOLOG. M. NEGRI

•\- Males and females aged 18\-60 years; \- First single kidney transplant from living or deceased donors; \- Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•\- Specific contraindications to RATG therapy such as severe leucopenia WBC 2000/mm3 ; \- High immunological risk such as second transplant recipients or those who have a panel reactivity 10 ; \- history of malignancy except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully; \- Evidence of active hepatitis C virus, hepatitis B virus or human acquired immunodeficiency virus infection; \- Any chronic clinical conditions that may affect completion of the trial or confound data interpretation; \- Pregnancy or lactating; \- Women of childbearing potential without following a scientifically accepted form of contraception; \- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial; \- Evidence of an uncooperative attitude; \- Any evidence that patient will not be able to complete the trial follow\-up.