Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

Phase 2TerminatedNCT00104338

Astellas Pharma Inc45 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

BK Polyomavirus Kidney Diseases

Interventions

FK778DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Los Angeles, California, United States

Outcomes

Primary Outcomes

Change from baseline in urine BK viral load

Secondary Outcomes

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

Data from ClinicalTrials.gov

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