A 12-month, multi-center, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican® (1.5 mg/day starting dose) with reduced Neoral® dose versus MMF with standard Neoral® dose in de novo heart transplant recipients. - RAD2411

• Conditions: Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic cardiac transplant in combination with ciclosporin for microemulsion and corticosteroids.; MedDRA version: 7.0Level: LLTClassification code 10050432

• Registration Number: EUCTR2004-001052-36-ES
• Lead Sponsor: ovartis Farmacéutica S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-09
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

•Male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation.
•Patients who have given written informed consent to participate in the study.
•Calculated creatinine clearance (by Cockroft-Gault) = 50 mL/min at screening

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

Exclusion Criteria

•Patients with platelet count <50,000/mm3 at the evaluation before randomization.
•Patients who are recipients of multiple solid organ transplants.
•Patients receiving induction therapy which is not standard per local practice
•Patients with clinically significant systemic infection.
•Patients receiving investigational agents in the 30 days prior to study entry.
•Known hypersensitivity to drugs of this class.
•Donor > 60 years and/or with known donor heart disease
•Patients with PRA >20%.
•Treatment with strong inducers or inhibitors of cytochrome P450 3A4.
•Cold ischemic time >6 hours.
•Unable to take oral medication.

Study & Design

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