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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099736
First Posted: December 20, 2004
Last Update Posted: August 22, 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: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 ( Novartis Pharmaceuticals ):

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

Enrollment: 696
Study Start Date: May 7, 2003
Study Completion Date: September 19, 2005
Primary Completion Date: September 19, 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
Experimental: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
Experimental: MMF 2 g + full-dose Neoral (FDN) + corticosteroids Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids
mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids

  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
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
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): 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, 44106
Cleveland, Ohio, United States, 44195
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00099736     History of Changes
Other Study ID Numbers: CFTY720A0125
CFTY720 0125 ( Other Identifier: Sponsor )
CFTY7200125 ( Other Identifier: Sponsor )
First Submitted: December 17, 2004
First Posted: December 20, 2004
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Fingolimod Hydrochloride
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Calcineurin Inhibitors