Clinical trial NCT00104338: Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: BK Polyomavirus
Kidney Diseases
Keywords: Investigational Therapies
Treatment Effectiveness
Treatment Efficacy
Immunosuppressant
BK Nephropathy
Polyomavirus, BK
Human Polyomavirus BK
Polyomavirus hominis 1
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2005-02-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change from baseline in urine BK viral load
Secondary outcomes:
measure: Change from baseline in plasma BK viral load
measure: 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
measure: Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: New Brunswick
country: United States
state: New Jersey
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Harrisburg
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Salt Lake City
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
Study officials:
References: