Trial record 1 of 1 for:
NCT 02771509
Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02771509 |
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Recruitment Status :
Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : July 15, 2021
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Sponsor:
Angion Biomedica Corp
Collaborators:
Everest Clinical Research
CTI Clinical Trial and Consulting Services
Clinical Accelerator
Information provided by (Responsible Party):
Angion Biomedica Corp
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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).
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Surgery
| Arm | Intervention/treatment |
|---|---|
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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.
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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
Other Name: Hepatocyte growth factor mimetic |
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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.
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Drug: Placebo
Normal saline
Other Name: Normal Saline |
Primary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
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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.
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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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
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
Locations
Show 40 study locations
Sponsors and Collaborators
Angion Biomedica Corp
Everest Clinical Research
CTI Clinical Trial and Consulting Services
Clinical Accelerator
Investigators
| Study Director: | John Neylan, MD | Angion Biomedica |
| Responsible Party: | Angion Biomedica Corp |
| ClinicalTrials.gov Identifier: | NCT02771509 |
| Other Study ID Numbers: |
002-15 |
| 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 |
Keywords provided by Angion Biomedica Corp:
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CPB Cardiac Surgery Acute Kidney Injury |
Additional relevant MeSH terms:
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Acute Kidney Injury Wounds and Injuries Renal Insufficiency Kidney Diseases Urologic Diseases Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Mitogens Mitosis Modulators Molecular Mechanisms of Pharmacological Action |