Back to resultsStudy of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
Primary Purpose
BK Polyomavirus, Kidney Diseases
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FK778
Sponsored by
About this trial
This is an interventional treatment trial for BK Polyomavirus focused on measuring Investigational Therapies, Treatment Effectiveness, Treatment Efficacy, Immunosuppressant, BK Nephropathy, Polyomavirus, BK, Human Polyomavirus BK, Polyomavirus hominis 1
Eligibility Criteria
Inclusion Criteria: Renal transplant recipient with newly diagnosed BK nephropathy. Exclusion Criteria: Previous treatment for BK nephropathy Organ transplant other than kidney Uncontrolled concomitant infection other than BK nephropathy
Sites / Locations
Outcomes
Primary Outcome Measures
Change from baseline in urine BK viral load
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00104338
First Posted
February 24, 2005
Last Updated
June 6, 2012
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00104338
Brief Title
Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
4. Oversight
5. Study Description
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.
Detailed Description
The purpose of this study is to assess the efficacy and safety of FK778 compared with standard care in renal transplant recipients with newly diagnosed and untreated BK nephropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BK Polyomavirus, Kidney Diseases
Keywords
Investigational Therapies, Treatment Effectiveness, Treatment Efficacy, Immunosuppressant, BK Nephropathy, Polyomavirus, BK, Human Polyomavirus BK, Polyomavirus hominis 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
FK778
Primary Outcome Measure Information:
Title
Change from baseline in urine BK viral load
Secondary Outcome Measure Information:
Title
Change from baseline in plasma BK viral load
Title
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
Title
Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Renal transplant recipient with newly diagnosed BK nephropathy.
Exclusion Criteria:
Previous treatment for BK nephropathy
Organ transplant other than kidney
Uncontrolled concomitant infection other than BK nephropathy
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
22710
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17104
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38014
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
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