Trials / Unknown
UnknownNCT02771509
Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
A Multicenter, Prospective, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of ANG-3777 to Assess the Safety and Efficacy of BB3 in Patients Developing Acute Kidney Injury After Cardiac Surgery
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 275 (actual)
- Sponsor
- Angion Biomedica Corp · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to assess the safety and efficacy of ANG-3777 in preventing AKI compared to placebo when administered to patients at risk for developing acute kidney injury (AKI) following cardiac surgical procedures involving cardiopulmonary bypass (CPB).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ANG-3777 | 6 mg/mL BB3, IV, 4 days in a row, first dose must be within 4 hours after surgery, the next three doses will be approx. 24 hours after the last dose |
| DRUG | Placebo | Normal saline |
Timeline
- Start date
- 2017-02-24
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2016-05-13
- Last updated
- 2021-07-15
Locations
40 sites across 4 countries: United States, Brazil, Canada, Georgia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02771509. Inclusion in this directory is not an endorsement.