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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282230
First Posted: January 26, 2006
Last Update Posted: June 7, 2012
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.
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
January 24, 2006
January 26, 2006
June 7, 2012
November 2003
Not Provided
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.
Not Provided
Complete list of historical versions of study NCT00282230 on ClinicalTrials.gov Archive Site
  • 6 month patient and graft survival rates
  • time to first biopsy confirmed acute rejection
  • clinically treated acute rejection episodes
  • treatment failure (up to 6 months)
  • renal function (SrCl and CrCl)
  • quantitation of CMV and polyomavirus viral load
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Prograf®/FK778 and Prograf®/MMF in De Novo Kidney Transplant Recipients
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
Drug: FK778
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
October 2005
Not Provided

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00282230
03-0-165
Not Provided
Not Provided
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma US, Inc.
Study Director: John Holman, MD Astellas Pharma US, Inc.
Astellas Pharma Inc
June 2012

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