Status:

TERMINATED

A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients

Lead Sponsor:

Astellas Pharma Inc

Collaborating Sponsors:

Astellas Pharma US, Inc.

Conditions:

Kidney Transplantation

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients

Eligibility Criteria

Inclusion

  • Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney.
  • Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.

Exclusion

  • Patient has received or is receiving an organ transplant other than kidney
  • Patient has received a kidney transplant from a cadaveric donor \>= 60 years of age.

Key Trial Info

Start Date :

November 1 2003

Trial Type :

INTERVENTIONAL

End Date :

October 1 2005

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT00282230

Start Date

November 1 2003

End Date

October 1 2005

Last Update

June 7 2012

Active Locations (23)

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Page 1 of 6 (23 locations)

1

Birmingham, Alabama, United States, 35294

2

Los Angeles, California, United States, 90057

3

San Diego, California, United States, 92123

4

Denver, Colorado, United States, 80262