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NCT00575419 · ClinicalTrials.gov registry record · Phase 1
Safety Study Of N-Acetylcysteine For Prevention Of Contrast Induced Nephropathy In Patients w/Stage 3 Renal Failure
A Phase 1 study, sponsored by Oregon Health and Science University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00575419 is a Phase 1 study that was terminated before completion, run by Oregon Health and Science University. The registered enrollment target is 6 participants.
The verdict
NCT00575419, a Phase 1 study, was terminated before completion, sponsored by Oregon Health and Science University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This will be a randomized prospective dose escalation clinical study of N-acetylcysteine (NAC) in patients with stage 3 or worse renal failure (Glomerular Filtration Rate 30-60 ml/min calculated with the Modification of Diet in Renal Disease formula), undergoing a procedure or imaging that requires the administration of contrast media at Oregon Health \& Science University or the Portland Veterans Hospital. Subjects will receive NAC 60 minutes prior to the procedure or imaging requiring contrast media. Toxicity will be graded according to NCI Common Toxicity Criteria (CTC) version 3.0. An adult Phase 1 dose escalation study of NAC administered intravenously (IV) and intra-arterially (IA) will be performed. An isotonic nonionic contrast agent will be used in all cases. Contrast Induced Nephropathy (CIN) is defined as an increase in serum creatinine concentration of 25% or more from the subjects baseline value within a 72-hour period after the administration of contrast media. Serum creatinine concentration will be measured at admission, every day during in-patient hospitalization, and at hospital discharge.
Interventions
- DRUG N-acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-11 |
| Est. Completion | 2014-09-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00575419
The ClinicalTrials.gov registry entry for NCT00575419 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which N-acetylcysteine is the first listed.
NCT00575419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00575419 about?
NCT00575419 is a clinical study titled "Safety Study Of N-Acetylcysteine For Prevention Of Contrast Induced Nephropathy In Patients w/Stage 3 Renal Failure". This will be a randomized prospective dose escalation clinical study of N-acetylcysteine (NAC) in patients with stage 3 or worse renal failure (Glomerular Filtration Rate 30-60 ml/min calculated with the Modification of Diet in Renal Disease formula), undergoing a procedure or imaging that requires ...
What is the current status of trial NCT00575419?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2007-11. Estimated completion is 2014-09-15.
What interventions are being tested in trial NCT00575419?
The interventions under investigation include: N-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT00575419?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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