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Long Term 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:
NCT00239811
First received: October 13, 2005
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

This study will evaluate the long term 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: Open Label
Primary Purpose: Treatment
Official Title: A Two-year Extension to 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 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, calculated creatinine clearance and urine-protein/creatinine ratio at Months 18, 24, 30 and 36
  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
  • Absolute lymphocyte count at Months 18, 24, 30 and 36.

Secondary Outcome Measures:
  • Physical examinations at Months 18, 24, 30 and 36
  • Vital signs at Months 18, 24, 30 and 36
  • Electrocardiogram at Months 24 and 36
  • Chest X-ray Months 24 and 36
  • Safety laboratory tests 18, 24, 30 and 36
  • Ophthalmic evaluations 18, 24, 30 and 36
  • AEs and SAEs
  • FTY720/CsA levels at Months 18, 24, 30 and 36

Estimated Enrollment: 684
Study Start Date: April 2004
Primary Completion Date: May 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 completed the 12 month core study
  • Patients who gave written informed consent to participate in the study Exclusion Criteria
  • Not applicable Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239811

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00239811     History of Changes
Other Study ID Numbers: CFTY720A0124E1
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