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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
History of Changes
  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:

U.S. FDA Resources

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099736

  Show 42 Study Locations
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 May 22, 2013