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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: Clinical Trial Phase 1 study, sponsored by Oregon Health and Science University.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00575419 stopped before completion
NCT00575419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which N-acetylcysteine is the first listed.
NCT00575419 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00575419's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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