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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02771509
• Other study ID #: 002-15
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 24, 2017
• Est. completion date: August 2021

Study information

• Verified date: July 2021
• Source: Angion Biomedica Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 275
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is either male or female = 18 years.

2. Patient has provided written informed consent, and is willing and able to comply with the requirements of the study protocol, including screening procedures.

3. Patient must be scheduled for and undergo a non-emergent cardiac surgical procedure

involving CPB. Eligible procedures include:

1. Coronary artery bypass graft (CABG) alone

2. Aortic valve replacement or repair alone, with or without aortic root repair

3. Mitral, tricuspid, or pulmonic valve replacement or repair alone

4. Combined replacement of several cardiac valves

5. CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair

6. CABG with combined cardiac valve replacement or repair.

4. Patient must have the following risk factor(s) for AKI prior to surgery:

1. Estimated glomerular filtration rate (eGFR) of = 20 and < 30 ml/min/1.73m2, or

2. eGFR = 30 and < 60 mL/min/1.73m2 and ONE of the following Additional Risk Factors (other than age = 75 years), or

3. 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.

5. 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.

6. Patient's body mass index (BMI) < 40 at Screening.

Exclusion Criteria:

1. Patient has eGFR < 20 mL/min/1.73 m2 within 48 hours pre-surgery as measured by MDRD 4.

2. 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.

3. Currently active infection requiring antibiotic treatment.

4. 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.

5. Administration of iodinated contrast material within 24 hours prior to cardiac surgery.

6. Patients diagnosed with AKI as defined by KDIGO criteria within 48 hours prior to surgery.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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
• Placebo
Normal saline

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina da UNESP Campus de Botucatu	Botucatu
Brazil	Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia (IC - FUC)	Porto Alegre
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)	Ribeirão Preto
Brazil	Fundação Faculdade Regional de Medicina de São José do Rio Preto	São José Do Rio Preto
Brazil	Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor - HCFMUSP)	São Paulo
Canada	London Health Sciences Center	London	Ontario
Canada	CHUM - Hôtel Dieu	Montréal	Quebec
Canada	MUHC - Royal Victoria Hospital	Montréal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec
Canada	St. John Regional Hospital	Saint John	New Brunswick
Canada	Saint Michael's Hospital	Toronto	Ontario
Georgia	Acad. G. Chapidze Emergency Cardiology Center	Tbilisi
Georgia	Bokhua Memorial Cardiovascular Center	Tbilisi
Georgia	Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi
Georgia	Jerarsi JSC	Tbilisi
Georgia	New Hospitals LTD	Tbilisi
Georgia	Tbilisi Heart Center	Tbilisi
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Suburban Hospital	Bethesda	Maryland
United States	University of Virginia Health System	Charlottesville	Virginia
United States	TriHealth	Cincinnati	Ohio
United States	Cleveland Clinic Fairview	Cleveland	Ohio
United States	Ohio State Wexner Medical Center	Columbus	Ohio
United States	Baylor Jack and Jane Hamilton Heart and Vascular center- Soltero Cardiovascular Research Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Indiana Ohio Heart	Fort Wayne	Indiana
United States	UF Health at Unviersity of Florida	Gainesville	Florida
United States	River City Clinical Research	Jacksonville	Florida
United States	Bryan Heart	Lincoln	Nebraska
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	MidMichigan Medical Center Midland	Midland	Michigan
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Cardiac & Vascular Research Center of Northern Michigan	Petoskey	Michigan
United States	California Institute of Renal Reseach	San Diego	California
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Angion Biomedica Corp	Clinical Accelerator, CTI Clinical Trial and Consulting Services, Everest Clinical Research

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean AUC of the percent increase in serum creatinine above baseline		starting from 24 hr after the end of CPB through Day 6