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Dopamine Agonist

Fenoldopam for Patent Ductus Arteriosus (Fenaki Trial)

Phase 2 & 3
Waitlist Available
Led By Jeffrey Segar, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 66 hrs - from 6 hrs before beginning of fenoldopam or placebo infusion up to 24 hours after the last dose of indomethacin
Awards & highlights

Fenaki Trial Summary

This study is evaluating whether a drug called fenoldopam may help reduce kidney damage in children who are undergoing a procedure to remove their tonsils.

Eligible Conditions
  • Patent Ductus Arteriosus
  • Acute Kidney Injury

Fenaki Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~66 hrs - from 6 hrs before beginning of fenoldopam or placebo infusion up to 24 hours after the last dose of indomethacin
This trial's timeline: 3 weeks for screening, Varies for treatment, and 66 hrs - from 6 hrs before beginning of fenoldopam or placebo infusion up to 24 hours after the last dose of indomethacin for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Level of Urine Albumin (mg/dl)
Change in Level of Urine Beta 2 Macroglobulin (mcg/ml)
Change in Level of Urine Cystatin C (mcg/ml)
+14 more

Fenaki Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FenoldopamExperimental Treatment1 Intervention
Infants in the experimental arm will receive fenoldopam (60 ug/ml; 0.1 ml/hr to provide 0.1ug/kg/min). If, after 6 hrs there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion will be increased to 0.2 ml/kg/hr (0.2 ug/kg/min for infants receiving fenoldopam). This rate will be continued throughout the remainder of the study.
Group II: ControlPlacebo Group1 Intervention
Infants in the Placebo arm will receive 0.9% sodium chloride (0.1 ml/hr). If, after 6 hrs there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion (in this arm the placebo) will be increased to 0.2 ml/kg/hr. This rate will be continued throughout the remainder of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenoldopam
FDA approved

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,600 Total Patients Enrolled
Jeffrey Segar, MDPrincipal Investigator - University of Iowa
Children'S Health System, Children'S Hospital Of Wisconsin, Children's Medical Group, Children's Physician Group PC, Infinity Healthcare Physicians SC
University Of Wisconsin Medical Sch (Medical School)
University Iowa Hosps & Clinics (Residency)
2 Previous Clinical Trials
84 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
Jeffrey Segar 2019. "Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02620761.
~0 spots leftby Apr 2025
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