Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
A Phase 2, Proof of Concept, Randomized, Open-label, Two-arm, Parallel Group, Multi-center Study to Assess the Efficacy and Safety of FK778 Compared With Standard Care in Renal Transplant Recipients With Untreated BK Nephropathy
1 other identifier
interventional
45
1 country
21
Brief Summary
The purpose of this study is to assess the safety and effectiveness of a new oral immunosuppressant agent compared to standard care in renal transplant patients diagnosed with BK nephropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2005
21 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
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 24, 2005
CompletedFirst Posted
Study publicly available on registry
February 25, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedJune 7, 2012
June 1, 2012
February 24, 2005
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in urine BK viral load
Secondary Outcomes (3)
Change from baseline in plasma BK viral load
Change from baseline in renal function as measured by serum creatinine (SCr) and creatinine clearance (CrCl) at month 6 or at the end of therapy, whichever is earlier
Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier
Interventions
Eligibility Criteria
You may qualify if:
- Renal transplant recipient with newly diagnosed BK nephropathy.
You may not qualify if:
- Previous treatment for BK nephropathy
- Organ transplant other than kidney
- Uncontrolled concomitant infection other than BK nephropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (21)
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Wichita, Kansas, 67214, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
New Brunswick, New Jersey, 08901, United States
Unknown Facility
Durham, North Carolina, 22710, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Harrisburg, Pennsylvania, 17104, United States
Unknown Facility
Memphis, Tennessee, 38014, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Fairfax, Virginia, 22031, United States
Related Publications (1)
Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
PMID: 39382091DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
February 24, 2005
First Posted
February 25, 2005
Study Start
January 1, 2005
Study Completion
August 1, 2006
Last Updated
June 7, 2012
Record last verified: 2012-06