Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00099749
First received: December 17, 2004
Last updated: November 1, 2011
Last verified: November 2011

December 17, 2004
November 1, 2011
November 2003
April 2006   (final data collection date for primary outcome measure)
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
To compare the efficacy and safety of FTY720 in kidney transplantation.
Complete list of historical versions of study NCT00099749 on ClinicalTrials.gov Archive Site
  • Safety/tolerability based on adverse event reporting.
  • BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
  • Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.
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Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Kidney Transplantation
Drug: FTY 720
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
Not Provided
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and Female
  • Between 18 to 65 years old

Exclusion Criteria:

  • Patients in need of multiple organ transplants
Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00099749
CFTY720A2218
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP