Last updated on August 2019

Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass

Brief description of study

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).

Detailed Study Description

Angion Biomedica Corp. has developed a small molecule hepatocyte growth factor/scatter factor (HGF/SF) mimetic, termed ANG-3777, which exerts significant nephroprotective effects in several preclinical renal injury models. Angion intends to develop ANG-3777 as a therapy to prevent and/or treat acute kidney injury. ANG-3777 is a new molecular entity and the proposed treatment is novel since no drug is currently available with an indication to prevent and/or treat acute kidney injury.

This is a randomized, prospective, parallel-group, double-blind, placebo-controlled, multicenter study. Patients who will be undergoing a surgical procedure involving CPB and are at elevated risk pre-surgery for AKI will be eligible to participate in the study. Patients will be randomized 1:1 to receive either ANG-3777 or placebo (normal saline) immediately after surgery. Study drug will be administered for a total of 4 daily intravenous (IV) infusions. The first post-operative dose MUST be started within 4 hours of completing CPB. The second dose will be administered 24 2 hours after completing CPB, and the third and fourth doses will be administered 24 2 hours after each previous dose.

Patients will be followed for safety, PK (in a subset of patients), and efficacy up to Day 90, with Day 1 being the day of the first infusion of study drug. Patients will be assessed daily through Day 7 and then on Days 14, 30 and 90.

Efficacy endpoints include assessment of post-CPB renal injury, expressed as percent increase in sCr above Baseline over time and the maximum percent increase in sCr following CPB, from 24 hours after end of CPB through Day 5; the proportion of patients reaching each KDIGO stage or having no AKI at specified time points through Day 30; and analyses among patients who develop AKI assessing time to recovery or reduction in KDIGO stage.

Approximately 240 patients will be randomized; 120 patients will be randomized to BB3 and 120 patients to placebo.

Clinical Study Identifier: NCT02771509

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