Clinical trial NCT02771509: Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Kidney Injury
Keywords: CPB
Cardiac Surgery
Acute Kidney Injury
Lead sponsor: Angion Biomedica Corp
Sponsor class: INDUSTRY
Collaborators: name: Everest Clinical Research
name: CTI Clinical Trial and Consulting Services
name: Clinical Accelerator
First posted: 2016-05-13
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The mean AUC of the percent increase in serum creatinine above baseline
timeFrame: starting from 24 hr after the end of CPB through Day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: California Institute of Renal Reseach
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Gainesville
country: United States
facility: UF Health at Unviersity of Florida
state: Florida
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: Fort Wayne
country: United States
facility: Indiana Ohio Heart
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Midland
country: United States
facility: MidMichigan Medical Center Midland
state: Michigan
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan
state: Michigan
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview
state: Ohio
city: Columbus
country: United States
facility: Ohio State Wexner Medical Center
state: Ohio
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular center- Soltero Cardiovascular Research Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Botucatu
country: Brazil
facility: Faculdade de Medicina da UNESP Campus de Botucatu
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia (IC - FUC)
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)
city: São José Do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor - HCFMUSP)
city: Saint John
country: Canada
facility: St. John Regional Hospital
state: New Brunswick
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Saint Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: CHUM - Hôtel Dieu
state: Quebec
city: Montréal
country: Canada
facility: MUHC - Royal Victoria Hospital
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: New Hospitals LTD
city: Tbilisi
country: Georgia
facility: Bokhua Memorial Cardiovascular Center
city: Tbilisi
country: Georgia
facility: Jerarsi JSC
city: Tbilisi
country: Georgia
facility: Tbilisi Heart Center
city: Tbilisi
country: Georgia
facility: Acad. G. Chapidze Emergency Cardiology Center
Study officials:
affiliation: Angion Biomedica
name: John Neylan, MD
role: STUDY_DIRECTOR
References: