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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 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.

Clinical Trial 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

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00104338
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Terminated
Phase Phase 2
Start date January 2005
Completion date August 2006
View Details
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