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NCT02620761 · ClinicalTrials.gov registry record · Phase 2
Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT02620761: Clinical Trial Phase 2 study, sponsored by Medical College of Wisconsin.
NCT02620761 is a Phase 2 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02620761, a Phase 2 study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon a difference in serum creatinine by one standard deviation. Fluid and salt intake will be held constant within clinical parameters and carefully measured. Fenoldopam will be started at 0.1 ug/kg/min. If, after 6 hrs there is no decrease in blood pressure, the dose will be increased to 0.2 ug/kg/min. This dose will be continued throughout the remainder of the study. A study of pediatric patients previously provided to the FDA showed no hypotension at a dose of 0.2 ug/kg/min. Fenoldopam will be started 12 hrs before the first dose of indomethacin and discontinued 12 hrs after the 3rd dose of indomethacin. Study samples will include both blood and urine. The primary outcome will be a reduction in renal dysfunction, as determined by creatinine and urine output over the course of treatment. Additional outcomes will include determination of known and novel metabolomic urine markers of renal dysfunction.
Primary Outcome
Urine will be collected and measured in 6 hour increments beginning 6 hours prior to starting fenoldopam or placebo infusion. The first dose of indomethacin will be given 12 hours after starting fenoldopam or placebo. Two additional doses of indomethacin will be given 12 hours apart. Urine will continue to be collected and volume measured in 6 hour increments up to 24 hrs after the last dose of indomethacin. To summarize, urine will be collected and measured from time -6 hours to 0 hours. Fenold
Interventions
- DRUG Fenoldopam
- DRUG 0.9%NS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-02-06 |
| Est. Completion | 2020-01-31 |
| Phase | Phase 2 |
Why NCT02620761 stopped before completion
NCT02620761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Fenoldopam is the first listed.
NCT02620761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02620761 about?
NCT02620761 is a clinical study titled "Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants". The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon a difference in serum creatinine by one standard deviation. Fluid and salt intake will be held constant within clin...
What is the current status of trial NCT02620761?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-02-06. Estimated completion is 2020-01-31.
What interventions are being tested in trial NCT02620761?
The interventions under investigation include: Fenoldopam (DRUG), 0.9%NS (DRUG).
Who is sponsoring clinical trial NCT02620761?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02620761's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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