de novo Kidney Transplantation
Conditions
Interventions
investigational material(s)
Generic name etc : Everolimus
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investiga
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: -Male or female de novo renal transplant recipients between 18 and 65 years of age -Patients who have given written informed consent to participate in the study -Females capable of becoming pregnant must have a negative pregnancy test prior to randomization. Exclusion Criteria: -Recipients of dual kidney transplants -Recipients of kidneys from HLA-identical living related donors -Donor organ with a cold ischemia time >24 hours -Donor age greater than 65 years -Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude renal biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed) Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy failure rate (treated BPAR, graft loss, death or loss to follow-up) [Time frame; 12 months] | — |
Outcome results
None listed