Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00104338
• Other study ID #: 04-0-196
• Status: Terminated
• Phase: Phase 2
• First received: February 24, 2005
• Last updated: June 6, 2012
• Start date: January 2005
• Est. completion date: August 2006

Study information

• Verified date: June 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• BK Polyomavirus
• Kidney Diseases

Intervention

Drug:
• FK778

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in urine BK viral load
Secondary	Change from baseline in plasma BK viral load
Secondary	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
Secondary	Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier