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Terminated Phase 2 Interventional

Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

ClinicalTrials.gov ID: NCT00104338

Public ClinicalTrials.gov record NCT00104338. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 4:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00104338
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Astellas Pharma Inc
Industry
Enrollment
45 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2005 (Type not available)
Primary completion
Not listed
Completion
Aug 2006 (Actual)
Last update posted
Jun 7, 2012

2005 – 2006

United States locations

U.S. sites
21
U.S. states
15
U.S. cities
18
Facility City State ZIP Site status
Not listed Los Angeles California 90057 —
Not listed Los Angeles California 90095 —
Not listed San Diego California 92123 —
Not listed San Francisco California 94115 —
Not listed San Francisco California 94143 —
Not listed Denver Colorado 80262 —
Not listed Washington D.C. District of Columbia 20010 —
Not listed Gainesville Florida 32610 —
Not listed Jacksonville Florida 32216 —
Not listed Atlanta Georgia 30322 —
Not listed Chicago Illinois 60612 —
Not listed Chicago Illinois 60637 —
Not listed Wichita Kansas 67214 —
Not listed Baltimore Maryland 21287 —
Not listed New Brunswick New Jersey 08901 —
Not listed Durham North Carolina 22710 —
Not listed Cincinnati Ohio 45267 —
Not listed Harrisburg Pennsylvania 17104 —
Not listed Memphis Tennessee 38014 —
Not listed Salt Lake City Utah 84132 —
Not listed Fairfax Virginia 22031 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00104338, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 7, 2012 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00104338 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →