prevention of acute rejection in maintenance renal transplant recipients MedDRA version: 7.0 Level: LLT Classification code 10023439
Conditions
Interventions
Product Name: FTY720
Product Code: FTY720
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not applicable
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: range
C
Sponsors
Novartis Farmacéutica S.A
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Spain
Outcome results
None listed