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Active Not RecruitingNCT04633889

Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
320 (actual)
Sponsor
Brigham and Women's Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Multiple lines of evidence support a central role of iron in causing acute kidney injury (AKI), including the finding that prophylactic administration of iron chelators attenuates AKI in animal models. Patients undergoing cardiac surgery may be particularly susceptible to iron-mediated kidney injury due to the profound hemolysis that often occurs from cardiopulmonary bypass. The investigators will test in a phase 2, randomized, double-blind, placebo-controlled trial whether prophylactic administration of deferoxamine decreases the incidence of AKI following cardiac surgery.

Conditions

Interventions

TypeNameDescription
DRUGDeferoxamineDeferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
DRUGNormal salineNormal saline (240mL) intravenous infusion over 12 hours

Timeline

Start date
2021-04-13
Primary completion
2024-08-26
Completion
2026-03-01
First posted
2020-11-18
Last updated
2026-01-26
Results posted
2026-01-26

Locations

3 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04633889. Inclusion in this directory is not an endorsement.