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
  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:


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
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: 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 September 18, 2014