Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| DRUG | Deferoxamine | Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours |
| DRUG | Normal saline | Normal 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04633889. Inclusion in this directory is not an endorsement.