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
1 other identifier
interventional
150
1 country
23
Brief Summary
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2003
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 24, 2006
CompletedFirst Posted
Study publicly available on registry
January 26, 2006
CompletedJune 7, 2012
June 1, 2012
January 24, 2006
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.
Secondary Outcomes (6)
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)
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (23)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Wichita, Kansas, 67214, United States
Unknown Facility
New Orleans, Louisiana, 70121, United States
Unknown Facility
Detroit, Michigan, 80262, United States
Unknown Facility
New Brunswick, New Jersey, 89003, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Harrisburg, Pennsylvania, 17104, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Memphis, Tennessee, 38163, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
John Holman, MD
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 24, 2006
First Posted
January 26, 2006
Study Start
November 1, 2003
Study Completion
October 1, 2005
Last Updated
June 7, 2012
Record last verified: 2012-06