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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099749
First Posted: December 20, 2004
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
Intervention Model: Parallel Assignment
Masking: Double
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 ( Novartis Pharmaceuticals ):

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Male and Female
  • Between 18 to 65 years old

Exclusion Criteria:

  • Patients in need of multiple organ transplants
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00099749     History of Changes
Other Study ID Numbers: CFTY720A2218
First Submitted: December 17, 2004
First Posted: December 20, 2004
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Kidney, immunosuppression, transplant, rejection

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