A 24-month, multicenter, randomized, open-label non-inferiority study of efficacy and safety comparing concentration-controlled Certican® in two doses (1.5 and 3.0 mg/day starting doses) with reduced Neoral® versus 1.44 g Myfortic ® with standard dose Neoral® in de novo renal transplant recipients -
- Conditions
- renal transplantation
- Registration Number
- EUCTR2005-002854-22-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
•Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation, females not pregnant or lactating
•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) yes
F.1.3.1 Number of subjects for this age range
•Patients with no evidence of graft funtion within 24 hours of transplantation are excluded.
•Cold ischemia time >40 hours, non-heartbeating donor , donor age >65
•Patients with platelet count <100,000/mm at the evaluation before randomization.
•Patients with an absolute neutrophil count of < 1,500/mm³ at baseline before surgery or white blood cell count of < 4,500/mm³
•Patients who are recipients of multiple solid organ or tissue transplants, or who previously received an organ or tissue transplant
•Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable
•Patients who have an abnormal liver profile such as ALT, AST, Alk Phos or total bilirubin >3 times the ULN
• Patients with a known hypersensitivity to either of the study drugs or their class, or to any of the excipients
•Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450, patients treated with terfenadine, astemizole or cisapride
• Patients who are unable to take oral medication at time of randomization.
•Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization
•Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized excised basal cell carcinoma of the skin
•Patients with most recent anti-HLA Class I Panel Reactive Antibodies >20% by a CDC- (Complement dependent cytotoxicity) based assay or >50% by a Flow Cytometry or ELISA (Enzyme linked Immunosorbent assay)- based assay, recipients of ABO incompatible transplants or T cell crossmatch positive transplant.
•Patients who have tested positive for HIV, Hepatitis C or Hepatitis B surface antigen. Laboratory results obtained within 6 months prior to randomization are acceptable, otherwise these tests should be performed within one week of randomization.
• Patients with clinically significant systemic infection at time of transplant or within two weeks of transplant.
•Recipients of Kidneys from HLA- identical living related donors
•Recipients of dual kidney transplants
•Recipients of organs from donors who test positive for Hepatitis B surface antigen, Hepatitis C or HIV are excluded
•Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
• Patients who have cardiac failure at time of screening (resting dyspnea, less than or equal to Grade 3 according to Old New York Heart Association Classification (Appendix 8) or any severe cardiac disease as determined by the investigator.
•Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication.
•Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the
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