Trial intelligence / Profile preview

Fenoldopam to Prevent Renal Dysfunction in Preterm Infants

NCT02620761Phase 3

Key facts

Status: Terminated
Start: Feb 2019
Primary completion: Jan 2020
Countries: 1
Sponsor: Medical College of Wisconsin
Modality: Classical Binding Small Molecules

Drugs: fenoldopam
Conditions: acute kidney injury (AKI)

Overview

Phase 3, randomised, double-blind trial of fenoldopam in acute kidney injury (AKI) (2 arms), sponsored by Medical College of Wisconsin. Primary endpoints: Changes in Urine Output at 66 hours and Changes in Serum Creatinine at 48 hours. Started Feb 2019; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Fenoldopam
Fenoldopam infusion (0.1-0.2 ug/kg/min) + Indomethacin
Control
Placebo infusion (0.9% NS) + Indomethacin

Who it enrols

Preterm infants (23-27 weeks GA) with PDA indicated for indomethacin closure, no prior indomethacin exposure, and no pre-existing renal dysfunction.

Endpoints

Primary

Changes in Urine Output66 hours
Changes in Serum Creatinine48 hours

Secondary

Serum Levels of Fenoldopam60 hours
Change in Levels of Serum Albumin48 hours
Change in Levels of Serum Cystatin C48 hours
Change in Levels of Serum Epidermal Growth Factor48 hours
Change in Levels of Serum Osteopontin48 hours
Change in Levels of Serum Uromodulin48 hours
Change in Level of Urine Albumin48 hours
Change in Level of Urine Beta 2 Macroglobulin48 hours

Beyond the preview

Go deeper on NCT02620761.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT02620761.