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 个研究点目标入组 224 人开始时间: 2007年1月5日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•- 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.

发起方

IST. DI RICERCHE FARMACOLOG. M. NEGRI