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NCT00099749 Clinical Trial

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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00099749
Other study ID # CFTY720A2218
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 17, 2004
Last updated February 21, 2017
Start date November 2003

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 255
Est. completion date
Est. primary completion date April 2006
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Male and Female

- Between 18 to 65 years old

Exclusion Criteria:

- Patients in need of multiple organ transplants

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• FTY 720

Locations
Country Name City State
United States St. Barnabas Medical Center Livingston New Jersey
United States Loyola University Medical Center Maywood Illinois
United States University of Pennsylvania Philadelphia Pennsylvania
United States Rhode Island Hospital Providence Rhode Island
United States SIU School of Medicine Springfield Illinois

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 stu — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
Secondary Safety/tolerability based on adverse event reporting.
Secondary BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
Secondary Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.
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