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

Phase 3CompletedNCT00099749

Novartis Pharmaceuticals255 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

255

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and Female * Between 18 to 65 years old Exclusion Criteria: * Patients in need of multiple organ transplants

Loyola University Medical Center

Maywood, Illinois, United States

SIU School of Medicine

Springfield, Illinois, United States

St. Barnabas Medical Center

Livingston, New Jersey, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.

Safety/tolerability based on adverse event reporting.

BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.

Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.

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