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

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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

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

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: FK778 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2003
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. 6 month patient and graft survival rates
  2. time to first biopsy confirmed acute rejection
  3. clinically treated acute rejection episodes
  4. treatment failure (up to 6 months)
  5. renal function (SrCl and CrCl)
  6. quantitation of CMV and polyomavirus viral load


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

ClinicalTrials.gov Identifier: NCT00282230     History of Changes
Other Study ID Numbers: 03-0-165
First Posted: January 26, 2006    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action