Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT00104338

Collaborator

Astellas Pharma US, Inc. (Industry)

Enrollment

Locations

Duration (Months)

2.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
BK Polyomavirus Kidney Diseases	Drug: FK778	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2005

Actual Study Completion Date :

Aug 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
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
5	San Francisco	California	United States	94143
6	Denver	Colorado	United States	80262
7	Washington	District of Columbia	United States	20010
8	Gainesville	Florida	United States	32610
9	Jacksonville	Florida	United States	32216
10	Atlanta	Georgia	United States	30322
11	Chicago	Illinois	United States	60612
12	Chicago	Illinois	United States	60637
13	Wichita	Kansas	United States	67214
14	Baltimore	Maryland	United States	21287
15	New Brunswick	New Jersey	United States	08901
16	Durham	North Carolina	United States	22710
17	Cincinnati	Ohio	United States	45267
18	Harrisburg	Pennsylvania	United States	17104
19	Memphis	Tennessee	United States	38014
20	Salt Lake City	Utah	United States	84132
21	Fairfax	Virginia	United States	22031