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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Page 1 of 6 (21 locations)

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