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Terminated Phase 1Phase 2 Interventional Results available

Cidofovir in Renal Transplant Recipients With BKVN

ClinicalTrials.gov ID: NCT00138424

Public ClinicalTrials.gov record NCT00138424. 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 23, 2026, 7:32 AM 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 Randomized, Placebo-Controlled, Dose-Escalation Study to Assess the Safety and Effect of Cidofovir in Renal Transplant Recipients With BK Virus Nephropathy

Brief summary

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

This study will look at the safety, tolerability and effectiveness of cidofovir in kidney transplant patients who have been diagnosed with BK virus nephropathy (BKVN), a viral condition that can cause patients to reject transplanted kidneys. Up to 48 adult (age 18 years and older) kidney or pancreas transplant recipients with newly diagnosed BKVN will receive 1 of 3 cidofovir dose levels or placebo (non medicated substance) to identify the maximum tolerated dose. Dosing will be administered intravenously (by a tube running into a blood vessel). In addition to the screening visit, volunteers will actively participate for approximately 8-10 weeks with a single follow up phone call at 4 months. Blood samples, urine samples, eye exams and physical exams are included in study procedures.

Study identification

NCT ID
NCT00138424
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
22 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
May 2006 (Type not available)
Primary completion
Jun 2010 (Actual)
Completion
Apr 2011 (Actual)
Last update posted
Mar 8, 2013

2006 – 2011

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
University of Alabama Hospital - Nephrology Birmingham Alabama 35249-0001 —
California Pacific Medical Center - Sutter Pacific Medical Foundation - Transplant Nephrology San Francisco California 94115-1932 —
University of California San Francisco Medical Center at Parnassus - Organ Transplant San Francisco California 94143-2204 —
University of Colorado Denver Aurora Colorado 80045-2541 —
Northwestern University - Comprehensive Transplant Center Chicago Illinois 60611-2927 —
The University of Chicago Medical Center - Kindney Trasnplant - Nephrology Chicago Illinois 60637-1447 —
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine Minneapolis Minnesota 55455-0356 —
Mayo Clinic, Rochester - Infectious Diseases Rochester Minnesota 55905-0001 —
Dartmouth-Hitchcock Medical Center - Infectious Disease Lebanon New Hampshire 03756-1000 —
Dallas Nephrology Associates - Dallas Transplant Institute Dallas Texas 75204-6168 —
University of Washington - Medicine Seattle Washington 98195-7110 —
University of Wisconsin Hospital and Clinics - Clinical Science Center - Nephrology Madison Wisconsin 53792-0001 —

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 NCT00138424, 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 Mar 8, 2013 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00138424 live on ClinicalTrials.gov.

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