A 24-month, multicenter, randomized, open label non inferiority study of efficay and safety comparing concentration- controlled Certican in two doses (1.5 and 3.0 mg/day starting doses) with reduced Neoral versus 1.44 Myfortic with standard dose Neoral in de-novo renal transplant recipients

• Conditions: Prevention of the rejection in adult patients receiving a de-novo renal transplant in combination with Neoral and corticosteroids; MedDRA version: 14.1Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2005-002854-22-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-01
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion criteria ? Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation, females not pregnant or lactating ? Recipients of primary cadaveric, living unrelated or non HLA identical living related donor ? 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: 0
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

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 ? 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

Study & Design

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