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-SE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-29
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 825

Inclusion Criteria

AMENDMENT 2 RELATED CHANGES SHOWN IN CAPITALS:

•Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation, females not pregnant or lactating ADDED:FEMALES MUST HAVE A NEGATIVE PREGNANCY TEST PRIOR TO RANDOMISATION
•Recipients of primary cadaveric, living unrelated or non HLA identical living related donor - THIS SENTENCE IS DELETED
•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

Exclusion Criteria

•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 transplants, or who previously received an organ 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 who are treated with drugs that are strong inducers or inhibitors of cytochrome P450, patients treated with terfenadine, astemizole, cisapride or lovastatin - LOVASTATIN IS DELETED
•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 basal cell carcinoma of the skin
•Patients with current Panel Reactive Antibodies >20%, recipients of ABO incompatible transplants or T cell crossmatch positive transplant.
•Patients who are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive. BECOMES: PATIENTS WHO HAVE TESTED POSITIVE FOR HIV, HEPATITIS C OR HEPATITIS B SURFACE ANTIGEN
•Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded
•Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
•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, and/or the presence of severe diarrhea or active peptic ulcer
•Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study
•Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation after transplantation. (Low dose aspirin treatment is allowed)
ADDED:
RECIPIENTS OF KIDNEYS FROM HLA-IDENTICAL LIVING RELATED DONORS
RECIPIENTS OF DUAL KIDNEY TRANSPLANTS
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified