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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099749
First Posted: December 20, 2004
Last Update Posted: February 23, 2017
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 )
December 17, 2004
December 20, 2004
February 23, 2017
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.
Not Provided
Not Provided
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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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Kidney Transplantation
Drug: FTY 720
Not Provided
Tedesco-Silva H, Szakaly P, Shoker A, Sommerer C, Yoshimura N, Schena FP, Cremer M, Hmissi A, Mayer H, Lang P; FTY720 2218 Clinical Study Group. FTY720 versus mycophenolate mofetil in de novo renal transplantation: six-month results of a double-blind study. Transplantation. 2007 Oct 15;84(7):885-92.

*   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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00099749
CFTY720A2218
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
February 2017

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