A one-year, multicenter, open-label, feasibility study to evaluate the safety and the efficacy of FTY720 5mg introduction and CNI elimination in adult maintenance renal transplant reicpients maintained on a triple immunosuppressive regimen with either MPA or mTOR inhibitor

Phase 1

• Conditions: prevention of acute rejection in maintenance renal transplant recipients; MedDRA version: 7.0Level: LLTClassification code 10023439

• Registration Number: EUCTR2004-000655-41-ES
• Lead Sponsor: ovartis Farmacéutica S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-03-10
• Study Start: 2005-12-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

male and female adults between 6 and 60 months post renal transplantation, maintained for the last 6 months on the same triple immunussupressive regimen : CNI + MPA + corticosteroids or CNI + mTOR + corticosteroids
stable renal function and no history of rejection
PRA <10% pre-transplantation
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

patient at high immunological risk of rejection
pulse rate < 50bpm at screening
presence or history of second or third degree AV block
history of cardiac arrest
history of malignancy
systemic infection within 2 weeks prior to start study medication
HIV or hepatitis B surface Ag positive

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate whether FTY720 can be safely introduced in a maintenance renal transplant population and can allow for CNI elimination resulting in an improvement of the renal function ;Secondary Objective: Validate discharge criteria following the first administration of FTY720;Primary end point(s): improvement of the renal function 12 months after FTY720 introduction, measured by the change in estimated glomerular filtration rate (Cockroft-Gault formula)