Renal Transplant MedDRA version: M15 Classification code 10023438
Conditions
Interventions
Trade Name: Certican®
Product Name: Certican®
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Novartis Farmacéutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each patient must meet all of the following inclusion criteria: 1. Male or female patients between 18 and 65 years of age 2. Male or female patients who are recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor . 3. The renal cold ischemic time (CIT) must be =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria at baseline will be excluded from study participation. 1. Patients who are recipients of multiple organ transplants including any organ other than kidney 2. Patients who have been previously transplanted with any organ other than a kidney 3. Recipients of non heart-beating donor organs 4. Patients with current or past panel reactive T-cell antibodies (PRA) titers of >50% 5. Patients that had been treated with any investigational drug 4 weeks before the baseline period 6. Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or hypersensitivity to drugs similar to RAD001 (e.g. macrolides) 7. Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment in this trial 8. Evidence of liver dysfunction as indicated by an abnormal liver profile (AST, ALT, alkaline phosphatase or total bilirubin = 3 times ULN) before transplantation 9. Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to randomization are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded. 10. Patients with symptoms of significant somatic or mental illness. Unresolved history of drug or alcohol abuse 11. Presence of revascularized ischemic heart disease or AMI, (or any cardiac disease considered to be unsafe for the study by the investigator) 12. Presence of severe hypercholesterolemia (= 350 mg/dL, 9.1 mmoL/dL) or hypertriglyceridemia (= 500mg/dL, 5.6 mmoL/L). Patients with controlled hyperlipidemia are acceptable 13. White blood cell (WBC) count= 3,500/mm3, or platelet count = 100,000/mm3 14. Patients with severe systemic infections 15. Patients with current or past malignancies (except for successfully treated localized basal cell carcinoma of the skin) 16. Patients who are recipients of A-B-O incompatible transplants or T-cell cross-match positive transplants 17. Patients with coagulopathy or any medical condition requiring long-term anticoagulation after transplantation (low dose aspirin is allowed) 18. Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to baseline visit, which at investigators discretion would interfere with the objectives of the study 19. Breast feeding women 20. Inability to cooperate or communicate with the investigator 21. Patients who have been treated with non-protocol immunosuppressive drug or treatment within 4 weeks prior to baseline visit Exclusion criteria for randomization at the end of month 3 (week 12): 1. Any episode of acute rejection grade IIb/III (Banff classification) or a vascular acute rejection in the previous 4 weeks or any episode of acute rejection episode during the month prior to randomization. 2. Patients depending on dialysis 3. Serum creatinine >3 mg/dL and/or more than 30% elevated during the previous month. 4. Patients who do not tolerate any increase in Certican ® dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The GFR value is calculated using the Nankivell formula. This is the end point in witch sample size is based. ;Main Objective: The primary objective is to compare renal function in the two treatment groups at month 12 post-transplant, as measured by calculated GFR (Nankivell), serum creatinine and calculated creatinine clearance (Cockroft- Gault). Intra-group change in GFR , as determined by Nankivell’s formula, and the GFR’s slope in the period between visits 6 and 12 months will also be determined. ;Secondary Objective: The secondary objectives of this study are: • To evaluate the incidence of biopsy-proven acute rejection (BPAR) episodes, graft loss, death or loss to follow-up after 12 months in both groups. • To evaluate the incidence of graft loss, death, BPAR episodes, antibody treated acute rejection episodes, clinically confirmed acute rejection episodes, clinically confirmed chronic rejection episodes and biopsy-proven chronic allograft nephropathy after 12 months in both groups. • To evaluate the safety of Certican® in combination with Simulect® and steroids, with either Neoral® discontinuation at 3 months post-transplant, or Neoral® minimization. | — |
Countries
Spain
Outcome results
None listed