Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
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|ClinicalTrials.gov Identifier: NCT02771509|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : July 15, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Drug: ANG-3777 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||275 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|
|Actual Study Start Date :||February 24, 2017|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
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 6 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patient is either male or female ≥ 18 years.
- Patient has provided written informed consent, and is willing and able to comply with the requirements of the study protocol, including screening procedures.
Patient must be scheduled for and undergo a non-emergent cardiac surgical procedure involving CPB. Eligible procedures include:
- Coronary artery bypass graft (CABG) alone
- Aortic valve replacement or repair alone, with or without aortic root repair
- Mitral, tricuspid, or pulmonic valve replacement or repair alone
- Combined replacement of several cardiac valves
- CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- CABG with combined cardiac valve replacement or repair.
Patient must have the following risk factor(s) for AKI prior to surgery:
- Estimated glomerular filtration rate (eGFR) of ≥ 20 and < 30 ml/min/1.73m2, or
- eGFR ≥ 30 and < 60 mL/min/1.73m2 and ONE of the following Additional Risk Factors (other than age ≥ 75 years), or
- eGFR ≥ 60 ml/min/1.73m2 and TWO of the following Additional Risk Factors
eGFR will be calculated using the abbreviated MDRD equation (MDRD-4, often referred to as the Levey equation): eGFR = 186.3 x sCr-1.154 x Age-0.203 x [0.742 if Female] x [1.212 if Black]
Additional Risk Factors:
- Combined valve and coronary surgery
- Previous cardiac surgery with sternotomy
- Left ventricular ejection fraction (LVEF) < 35% by invasive or noninvasive diagnostic cardiac imaging within 90 days prior to surgery
- Diabetes mellitus requiring insulin treatment
- Non-insulin-requiring diabetes with documented presence of at least moderate (+2 or > 100 mg/dL) proteinuria on urine analysis (medical history or dipstick)
- Documented NYHA Class III or IV within 1 year prior to index surgery
- Age ≥ 75 years can be considered an Additional Risk Factor only for patients with eGFR ≥ 60 ml/min/1.73m2.
- Patient must have presented for surgery without prior evidence of active renal injury defined as no acute rise in sCr > 0.3 mg/dL or no 50% increase in sCr between the time of Screening and pre-surgery.
- Patient's body mass index (BMI) < 40 at Screening.
- Patient has eGFR < 20 mL/min/1.73 m2 within 48 hours pre-surgery as measured by MDRD 4.
- Patient has ongoing sepsis or partially treated infection. Sepsis is defined as the presence of a confirmed pathogen, along with fever or hypoperfusion (i.e., acidosis and new onset elevation of liver function tests) or hypotension requiring pressor use prior to surgery.
- Currently active infection requiring antibiotic treatment.
- Patient who has an active (requiring treatment) malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
- Administration of iodinated contrast material within 24 hours prior to cardiac surgery.
- Patients diagnosed with AKI as defined by KDIGO criteria within 48 hours prior to surgery.
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
|Study Director:||John Neylan, MD||Angion Biomedica|
|Responsible Party:||Angion Biomedica Corp|
|Other Study ID Numbers:||
|First Posted:||May 13, 2016 Key Record Dates|
|Last Update Posted:||July 15, 2021|
|Last Verified:||July 2021|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Acute Kidney Injury
Acute Kidney Injury
Wounds and Injuries
Molecular Mechanisms of Pharmacological Action