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NCT00138424 · ClinicalTrials.gov registry record · Phase 1

Cidofovir in Renal Transplant Recipients With BKVN

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Terminated
Registry status
Phase 1
Development phase
22
Enrollment target

NCT00138424 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 22 participants.

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The verdict

NCT00138424, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

TERMINATED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG Cidofovir

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2006-05
Est. Completion 2011-04
Phase Phase 1

What the Registry Record Tells You About NCT00138424

The ClinicalTrials.gov registry entry for NCT00138424 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00138424 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00138424 about?

NCT00138424 is a clinical study titled "Cidofovir in Renal Transplant Recipients With BKVN". 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...

What is the current status of trial NCT00138424?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2006-05. Estimated completion is 2011-04.

What interventions are being tested in trial NCT00138424?

The interventions under investigation include: Placebo (DRUG), Cidofovir (DRUG).

Who is sponsoring clinical trial NCT00138424?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.