Clinical Trials Directory

Trials / Terminated

TerminatedNCT00104338

Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
45 (planned)
Sponsor
Astellas Pharma Inc · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGFK778

Timeline

Start date
2005-01-01
Completion
2006-08-01
First posted
2005-02-25
Last updated
2012-06-07

Locations

21 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00104338. Inclusion in this directory is not an endorsement.