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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00099736
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: FTY720
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: Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
  • permanent resumption of dialysis within 12 months post transplant
  • surgical removal of graft within 12 months post transplant
  • death within 12 months post transplant
  • withdrawal of consent, death, or lost to follow up within 12 months post transplant

Secondary Outcome Measures:
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
  • serum creatinine
  • cystatin C at months 3, 6, and 12
  • proteinuria at day 28, months 6 and 12
  • absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12

Estimated Enrollment: 684
Study Start Date: May 2003
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First kidney transplantation
  • Male and female patients
  • Between 18 and 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: NCT00099736

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85054
United States, California
Los Angeles, California, United States, 90057
Palo Alto, California, United States, 94303
San Francisco, California, United States, 94143
United States, Colorado
Denver, Colorado, United States, 80262
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, Florida
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30309
Atlanta, Georgia, United States, 30322
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Iowa
Des Moines, Iowa, United States, 50309
United States, Maine
Portland, Maine, United States, 04102
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02215
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
Rochester, Minnesota, United States, 55905
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
Livingston, New Jersey, United States, 07039
United States, New York
Hawthorne, New York, United States, 10523
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44195
Cleveland, Ohio, United States, 44106
Toledo, Ohio, United States, 43614
United States, Oregon
Portland, Oregon, United States, 97232
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Memphis, Tennessee, United States, 38103
Nashville, Tennessee, United States, 37212
United States, Texas
Dallas, Texas, United States, 75246
Galveston, Texas, United States, 77555
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Fairfax, Virginia, United States, 22042
Richmond, Virginia, United States, 23298
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00099736     History of Changes
Other Study ID Numbers: CFTY720A0125
Study First Received: December 17, 2004
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 31, 2014