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

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.
 
ClinicalTrials.gov Identifier: NCT00282230
Recruitment Status : Terminated
First Posted : January 26, 2006
Last Update Posted : June 7, 2012
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE January 24, 2006
First Posted Date  ICMJE January 26, 2006
Last Update Posted Date June 7, 2012
Study Start Date  ICMJE November 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2007)
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
Official Title  ICMJE 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
Brief Summary A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplantation
Intervention  ICMJE Drug: FK778
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: February 5, 2007)
150
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282230
Other Study ID Numbers  ICMJE 03-0-165
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Astellas Pharma US, Inc.
Investigators  ICMJE
Study Director: John Holman, MD Astellas Pharma US, Inc.
PRS Account Astellas Pharma Inc
Verification Date June 2012

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