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
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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014