kidney transplant MedDRA version: 6.1 Level: PT Classification code 10023439
Conditions
Interventions
Trade Name: CELLCEPT*50CPR 500MG
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: AZATIOPRINA WELL*50CPR RIV50MG
Pharm
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the incidence of CAN in kidney transplant patients receiving induction therapy with basiliximab and low-dose RATG and maintenance immunosuppression with low-dose MMF or AZA monotherapy.;Secondary Objective: - To evaluate whether MMF may exert an higher activity against acute allograft rejection as compared to AZA when used as the sole immunosuppressive agent. - To evaluate the relationships between acute rejection episodes and subsequent occurrence of CAN, and long-term graft function/survival. Should the study demonstrate the superiority of any of the two drugs in preventing CAN, patients will be put on the more effective immunosuppressive treatment. This will allow assessing whether the lesions of CAN may recover in those patients who are shifted from the less to the more effective treatment. The extension phase of the study will be aimed at assessing the long-term patient and graft survival.;Primary end point(s): Incidence of biopsy-proven CAN at 3 years follow-up end phase B . | — |
Countries
Italy
Outcome results
None listed