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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000587-26-HU

Enrollment

690

Registered

2004-11-10

Start date

2005-02-01

Completion date

Unknown

Last updated

2015-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis of kidney allograft rejection in de novo adult renal transplant recipients MedDRA version: 7.0 Level: LLT Classification code 10023439

Interventions

Product Name: FTY720 Product Code: FTY720 Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: CellCept Product Name:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.;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	—

Measure

Time frame

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.;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

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Countries

Germany, Hungary, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026