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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00239902
First Posted: October 17, 2005
Last Update Posted: November 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two-year Extension of a One-year, Multicenter, Randomized, Partially-blinded Study of the Safety and Efficacy of FTY720 Combined With Corticosteroids and Full or Reduced-dose Cyclosporine, USP [Modified] (Novartis Brand) in de Novo Adult Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • IA, IB, IIA, IIB or III 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
  • Discontinuation within 36 months post transplant

Secondary Outcome Measures:
  • FEV1 , FVC, DLCO within 36 months post transplant
  • Serum creatinine and estimated creatinine clearance within 36 months post transplant
  • Absolute lymphocyte count within 36 months post transplant

Estimated Enrollment: 396
Study Start Date: May 2002
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria

- Completion of Core study

Exclusion Criteria

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239902


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00239902     History of Changes
Other Study ID Numbers: CFTY720A0121E1
First Submitted: October 13, 2005
First Posted: October 17, 2005
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Transplantation, kidney, and organ transplantation

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