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

NCT02771509 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 002-15
• Study Type: interventional
• Target: 275
• Locations: 4 countries
• Sites: 40

Brief 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

Acute Kidney Injury

Keywords

CPB; Cardiac Surgery; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• The mean AUC of the percent increase in serum creatinine above baseline

  starting from 24 hr after the end of CPB through Day 6

Study Arms (2)

ANG-3777

ACTIVE COMPARATOR

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.

Drug: ANG-3777

Normal Saline

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

ANG-3777 DRUG

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

Also known as: Hepatocyte growth factor mimetic

ANG-3777

Placebo DRUG

Normal saline

Also known as: Normal Saline

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angion Biomedica Corp: lead
• Everest Clinical Research: collaborator
• CTI Clinical Trial and Consulting Services: collaborator
• Clinical Accelerator: collaborator

Study Sites (40)

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

California Institute of Renal Reseach

San Diego, California, 92123, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32207, United States

Location

UF Health at Unviersity of Florida

Gainesville, Florida, 32610, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

Indiana Ohio Heart

Fort Wayne, Indiana, 46804, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

MidMichigan Medical Center Midland

Midland, Michigan, 49770, United States

Location

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

TriHealth

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic Fairview

Cleveland, Ohio, 44111, United States

Location

Ohio State Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Baylor Jack and Jane Hamilton Heart and Vascular center- Soltero Cardiovascular Research Center

Dallas, Texas, 75226, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Faculdade de Medicina da UNESP Campus de Botucatu

Botucatu, 18618-686, Brazil

Location

Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia (IC - FUC)

Porto Alegre, 90040-371, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)

Ribeirão Preto, 14048-900, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, 15090-000, Brazil

Location

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor - HCFMUSP)

São Paulo, 05403-000, Brazil

Location

St. John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

Saint Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

CHUM - Hôtel Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

MUHC - Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

New Hospitals LTD

Tbilisi, 0114, Georgia

Location

Bokhua Memorial Cardiovascular Center

Tbilisi, 0159, Georgia

Location

Jerarsi JSC

Tbilisi, 0167, Georgia

Location

Tbilisi Heart Center

Tbilisi, 0186, Georgia

Location

Acad. G. Chapidze Emergency Cardiology Center

Tbilisi, 0519, Georgia

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

terevalefim; Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• John Neylan, MD

  Angion Biomedica

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: May 13, 2016
• Study Start: February 24, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

CA (6); GE (6); US (23); BR (5)