Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

Astellas

Status and phase: Terminated; Phase 2

Conditions: Kidney Diseases; BK Polyomavirus

Treatments: Drug: FK778

Study type: Interventional

Funder types: Industry

Identifiers

NCT00104338

04-0-196

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)