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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00099749
First received: December 17, 2004
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Kidney Transplantation
Drug: FTY 720
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 255
Study Start Date: November 2003
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Male and Female
  • Between 18 to 65 years old

Exclusion Criteria:

  • Patients in need of multiple organ transplants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099749

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
SIU School of Medicine
Springfield, Illinois, United States, 62781
United States, New Jersey
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00099749     History of Changes
Other Study ID Numbers: CFTY720A2218
Study First Received: December 17, 2004
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Kidney, immunosuppression, transplant, rejection

Additional relevant MeSH terms:
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014