Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant

Phase 3

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids; Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids; Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids

• Registration Number: NCT00099736
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05-07
• Study First Submitted: 2004-12-17
• Study First Submitted QC: 2004-12-17
• Study First Posted: 2004-12-20
• Primary Completion: 2005-09-19
• Study Completion: 2005-09-19
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 696

Inclusion Criteria

• First kidney transplantation
• Male and female patients
• Between 18 and 65 years old

Exclusion Criteria

• Patients in need of multiple organ transplants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,	FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids	-
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids	FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids	-
MMF 2 g + full-dose Neoral (FDN) + corticosteroids	MMF 2 g + full-dose Neoral (FDN) + corticosteroids	-

Primary Outcome Measures

Name	Time	Method
death within 12 months post transplant
withdrawal of consent, death, or lost to follow up within 12 months post transplant
surgical removal of graft within 12 months post transplant
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
permanent resumption of dialysis within 12 months post transplant

Secondary Outcome Measures

Name	Time	Method
absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
cystatin C at months 3, 6, and 12
serum creatinine
proteinuria at day 28, months 6 and 12