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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2006-05 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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