A 12 month, multicenter, randomized, parallel, open-label study, to evaluate renal function and efficacy of Certican® (everolimus) with Simulect® (basiliximab) and cyclosporine discontinuation at 3 month post-transplant vs minimization, in de novo kidney transplant recipients - CERTES02
- Conditions
- Renal TransplantMedDRA version: M15Classification code 10023438
- Registration Number
- EUCTR2005-000380-26-ES
- Lead Sponsor
- ovartis Farmacéutica S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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 < 36 hours
4. The age of the donor must be < 65 years
5. Females of childbearing potential must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication.
6. Patients who have given written informed consent to participate in the study
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method