A two-year extension to a one-year, multicenter, partially blinded, double-dummy, randomized study to evaluate the efficacy and safety of FTY720 combined with reduced-dose or full-dose Neoral and corticosteroids versus mycophenolate mofetil (MMF, CellCept) combined with full-dose Neoral and corticosteroids, in de novo adult renal transplant recipients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004958-63-DE

Enrollment

718

Registered

2005-06-23

Start date

2005-08-04

Completion date

Unknown

Last updated

2012-03-19

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, hard CAS Number: 162359-56-0 Current Sponsor code: FTY720 Concentration unit: mg milligram(s) Concentration type: equal Concentr

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) and has been maintained on study medication (FTY720/Neoral or MMF/Neoral in combination with corticosteroids), consistent with their original randomization, at their Month 12 visit. 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 drug(s). 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 purpose of this two-year extension is to allow patients who have completed the one-year core study to continue treatment with FTY720 or MMF in combination with reduced or full-dose Neoral (per randomized treatment assignment) beyond the first year post-transplantation for a total of three years follow-up. ;Secondary Objective: The two-year extension will provide long term efficacy and safety data on all patients enrolled into the core study.;Primary end point(s): Biopsy proven acute rejection, graft loss, death and discontinuation from the study.	—

Measure

Time frame

Main Objective: The purpose of this two-year extension is to allow patients who have completed the one-year core study to continue treatment with FTY720 or MMF in combination with reduced or full-dose Neoral (per randomized treatment assignment) beyond the first year post-transplantation for a total of three years follow-up. ;Secondary Objective: The two-year extension will provide long term efficacy and safety data on all patients enrolled into the core study.;Primary end point(s): Biopsy proven acute rejection, graft loss, death and discontinuation from the study.

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Countries

Germany, Italy

Outcome results

None listed

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