Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
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|ClinicalTrials.gov Identifier: NCT02771509|
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Drug: ANG-3777 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Active Comparator: ANG-3777
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. Duration of administration is 30 minutes.
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
Other Name: Hepatocyte growth factor mimetic
Placebo Comparator: Normal Saline
The placebo 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. Duration of administration is 30 minutes.
Other Name: Normal Saline
- The mean AUC of the percent increase in serum creatinine above baseline [ Time Frame: starting from 24 hr after the end of CPB through Day 5 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771509
|Contact: Gabrielle Pelleemail@example.com|
|United States, California|
|Stanford University Medical Center||Recruiting|
|Palo Alto, California, United States, 94304|
|California Institute of Renal Reseach||Recruiting|
|San Diego, California, United States, 92123|
|United States, Connecticut|
|Yale University School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06520|
|United States, Florida|
|UF Health at Unviersity of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|River City Clinical Research||Recruiting|
|Jacksonville, Florida, United States, 32207|
|United States, Maryland|
|University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Bethesda, Maryland, United States, 20814|
|United States, Michigan|
|MidMichigan Medical Center Midland||Recruiting|
|Midland, Michigan, United States, 49770|
|Cardiac & Vascular Research Center of Northern Michigan||Recruiting|
|Petoskey, Michigan, United States, 49770|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland Clinic Fairview||Recruiting|
|Cleveland, Ohio, United States, 44111|
|United States, Texas|
|Baylor Jack and Jane Hamilton Heart and Vascular center- Soltero Cardiovascular Research Center||Recruiting|
|Dallas, Texas, United States, 75226|
|Study Director:||John Neylan, MD||Angion Biomedica|