Status:
TERMINATED
Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
BK Polyomavirus
Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Renal transplant recipient with newly diagnosed BK nephropathy.
Exclusion
- Previous treatment for BK nephropathy
- Organ transplant other than kidney
- Uncontrolled concomitant infection other than BK nephropathy
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00104338
Start Date
January 1 2005
End Date
August 1 2006
Last Update
June 7 2012
Active Locations (21)
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1
Los Angeles, California, United States, 90057
2
Los Angeles, California, United States, 90095
3
San Diego, California, United States, 92123
4
San Francisco, California, United States, 94115