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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:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00282230
First received: January 24, 2006
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Kidney Transplantation
 Drug: FK778
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: November 2003
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282230

  Show 23 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Investigators
Study Director: John Holman, MD Astellas Pharma US, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00282230     History of Changes
Other Study ID Numbers: 03-0-165
Study First Received: January 24, 2006
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Malononitrilamide
immunosuppression
treatment efficacy
treatment outcome

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013