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Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00239798
First received: October 13, 2005
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.


Condition Intervention Phase
Renal Transplantation
Drug: FTY720
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 24-month Extension of a One-year, Multicenter, Double Blinded Double Dummy, Randomized Study to Evaluate the Safety and Efficacy of Two Doses of FTY720 Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids, in Adult de Novo Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • IA, IB, IIA, IIB, III, or humoral acute rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
  • Permanent resumption of dialysis within 36 months post transplant
  • Surgical removal of graft within 36 months post transplant
  • Death within 36 months post transplant
  • Withdrawal of consent, death, or lost to follow up within 36 months post transplant
  • Serum creatinine, and estimated creatinine clearance within 36 months post transplant
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant
  • Absolute lymphocyte count within 36 months post transplant

Secondary Outcome Measures:
  • IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant
  • Permanent resumption of dialysis at Month 24 and Month 36 post-transplant
  • Surgical removal of graft at Month 24 and Month 36 post-transplant
  • Death at Month 24 and Month 36 post-transplant
  • Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant
  • Serum creatinine, and estimated creatinine clearance at Month 24 and Month 36 post-transplant
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Month 24 and Month 36 post-transplant
  • Absolute lymphocyte count at Month 18, 24, 30 and 36

Estimated Enrollment: 255
Study Start Date: November 2004
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria

  • Patients who have completed the 12 Month visit of the Core trial either on or off study drug.
  • Female capable of becoming pregnant are required to have a medically approved method of birth control until 3 Month after study medication was stopped.

Exclusion Criteria

- None

  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: NCT00239798

Sponsors and Collaborators
Novartis Pharmaceuticals
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00239798     History of Changes
Other Study ID Numbers: CFTY720A2218E1
Study First Received: October 13, 2005
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Transplantation, kidney, organ transplant

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

ClinicalTrials.gov processed this record on November 24, 2014