Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00099801
First received: December 21, 2004
Last updated: January 14, 2014
Last verified: January 2014
  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:


Further study details as provided by Novartis:

Study Start Date: January 2005
Study Completion Date: March 2006
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
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: 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: January 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Kidney, Transplantation, Rejection, Immunosuppression

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

ClinicalTrials.gov processed this record on November 25, 2014