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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00104338
Enrollment
45
Registered
2005-02-25
Start date
2005-01-31
Completion date
2006-08-31
Last updated
2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BK Polyomavirus, Kidney Diseases

Keywords

Investigational Therapies, Treatment Effectiveness, Treatment Efficacy, Immunosuppressant, BK Nephropathy, Polyomavirus, BK, Human Polyomavirus BK, Polyomavirus hominis 1

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.

Interventions

DRUGFK778

Sponsors

Astellas Pharma US, Inc.
CollaboratorINDUSTRY
Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in urine BK viral load—

Secondary

MeasureTime frame
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—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026