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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014