Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Novartis Pharmaceuticals255 enrolled

Overview

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

255

Conditions

Renal Transplantation

Interventions

FTY720DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients who have completed the 12 Month visit of the Core trial either on or off study drug. * Female capable of becoming pregnant are required to have a medically approved method of birth control until 3 Month after study medication was stopped. Exclusion Criteria \- None

Outcomes

Primary Outcomes

IA, IB, IIA, IIB, III, or humoral acute rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant

Permanent resumption of dialysis within 36 months post transplant

Surgical removal of graft within 36 months post transplant

Death within 36 months post transplant

Withdrawal of consent, death, or lost to follow up within 36 months post transplant

Serum creatinine, and estimated creatinine clearance within 36 months post transplant

FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant

Absolute lymphocyte count within 36 months post transplant

Secondary Outcomes

IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant

Permanent resumption of dialysis at Month 24 and Month 36 post-transplant

Surgical removal of graft at Month 24 and Month 36 post-transplant

Death at Month 24 and Month 36 post-transplant

Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant

Serum creatinine, and estimated creatinine clearance at Month 24 and Month 36 post-transplant

Data from ClinicalTrials.gov

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