Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

Phase 2

Terminated

• Conditions: BK Polyomavirus; Kidney Diseases

• Registration Number: NCT00104338
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-02-24
• Study First Submitted QC: 2005-02-24
• Study First Posted: 2005-02-25
• Study Completion: 2006-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in urine BK viral load

Secondary Outcome Measures

Name	Time	Method
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