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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00239785
First received: October 13, 2005
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Renal 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: A One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients

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: April 2003
Primary Completion Date: April 2005 (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

  • Male and female patients of any race between 18 to 65 years old (inclusive)
  • Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation
  • Patients who gave written informed consent to participate in the study Exclusion Criteria
  • Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
  • Graft cold ischemia time greater than 40 hours.
  • Patients with pulse rate < 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239785

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00239785     History of Changes
Other Study ID Numbers: CFTY720A0124
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, and organ transplant.

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

ClinicalTrials.gov processed this record on May 16, 2013