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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00099801
First received: December 21, 2004
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

The safety and efficacy 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: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Study Start Date: December 2004
Primary Completion Date: March 2006 (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:

  • Patients undergoing their first kidney transplant
  • Male or female age 18 to 65 years

Exclusion Criteria:

  • Patients in need of second kidney transplant or multi-organ transplants.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099801

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00099801     History of Changes
Other Study ID Numbers: CFTY720A2307
Study First Received: December 21, 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 May 23, 2013