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

Phase 2

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT00099749
• 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: 2003-11
• Study First Submitted: 2004-12-17
• Study First Submitted QC: 2004-12-17
• Study First Posted: 2004-12-20
• Primary Completion: 2006-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• Male and Female
• Between 18 to 65 years old

Exclusion Criteria

• Patients in need of multiple organ transplants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.
Safety/tolerability based on adverse event reporting.
BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.

Trial Locations

Locations (5)

SIU School of Medicine; 🇺🇸 Springfield, Illinois, United States

St. Barnabas Medical Center; 🇺🇸 Livingston, New Jersey, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States