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

Phase 1

• Conditions: kidney transplant; MedDRA version: 6.1Level: PTClassification code 10023439

• Registration Number: EUCTR2006-005604-14-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-05
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified