A 24-month Extension to a one-year, multicentre, double-blinded, double-dummy, randomized study to evaluate the safety and efficacy of two doses of FTY720 combined with full-dose Neoral and steroids versus Cellcept combined with full-dose Neoral and steroids, in de novo adult renal transplant recipients.

• Conditions: Prophylaxis of kidney allograft rejection in de novo adult renal transplant recipients; MedDRA version: 7.0Level: LLTClassification code 10023439

• Registration Number: EUCTR2004-000587-26-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 690

Inclusion Criteria

a)The patient has given written informed consent to participate in the extension study.
b)The patient has completed the core study (through 12 months post-transplantation, either being maintained on study medication or having attended the Follow-up visits up to Month 12 after being discontinued from study medication).
c)Females capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study medication.

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 any medical or psychosocial condition which the investigator believes would hinder compliance with the study requirements.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To provide continued treatment for patients who have completed the 12-month core study on study medication.;Primary end point(s): Biopsy-proven acute rejection, graft loss, death or discontinuation from study;Main Objective: The objective of this extension is to assess long-term safety and efficacy data of two doses of FTY720 (2.5 or 5.0 mg) combined with full dose Neoral and steroids versus MMF combined with full dose Neoral and steroids in de novo adult renal transplant recipients beyond 12 months post-transplantation.