Acute Kidney InjuryPhase 2NCT01777165
A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery
A Phase 2 study testing ABT-719 in people with Acute Kidney Injury, run by AbbVie at 41 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- ABT-719
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 41 sitesin 2 countries
- Study dates
- Feb 2013to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be male or female, age greater than or equal to 18 years old.
- Subjects must have stable renal function, per Investigator discretion and no known increase in serum creatinine of greater than or equal to 0.3 mg during the preceding 4 weeks.
- Subjects with estimated glomerular filtration rate less than or equal to 60 mL/min/1.73 m2 who require intravascular iodinated contrast within 48 hours of the day of surgery, will only be included if there is no known serum creatinine increase greater than or equal to 0.3 mg.
- Subjects must be undergoing a pre-defined on-pump cardiac surgery meeting one of the following acute kidney injury risk factors:
- Subject is undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
- Subject is undergoing surgery of more than one cardiac valve (valves surgery), or
Show all 9Show fewer
- Subject is undergoing surgery of the aortic root or ascending part of the aorta, or
- Subject is undergoing surgery of the aortic root or ascending part of the aorta, combined with coronary artery bypass graft and/or valve(s) surgery, or
- Subject has an estimated glomerular filtration rate greater than or equal to 16 mL/min/1.73 m2 and less than or equal to 59 mL/min/1.73 m2 as determined by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at Screening, and is undergoing coronary artery bypass graft or single valve surgery.
Who cannot join
- Has an eGFR less than or equal to 15 mL/min/1.73 m2.
- Cardiac surgery to be performed without cardiopulmonary bypass.
- Has ongoing sepsis or history of sepsis within the last 2 weeks or untreated diagnosed infection prior to Screening visit. Sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension.
- Has known or documented RIFLE "R" or AKIN "Stage I" within the previous 4 weeks.
- Recently received (within the last 10 weeks) or is anticipated to receive chemotherapy which can interfere with kidney function
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States38 sites
Site Reference ID/Investigator# 89176
Asheville, North Carolina, 28803
Site Reference ID/Investigator# 87693
Atlanta, Georgia, 30322
Site Reference ID/Investigator# 87717
Augusta, Georgia, 30912
Site Reference ID/Investigator# 83732
Bethesda, Maryland, 20814
Site Reference ID/Investigator# 83724
Boston, Massachusetts, 02115
Site Reference ID/Investigator# 83745
Boston, Massachusetts, 02135
Site Reference ID/Investigator# 90614
Charlottesville, Virginia, 22908
Site Reference ID/Investigator# 83735
Cincinnati, Ohio, 45219
Site Reference ID/Investigator# 91813
Columbus, Ohio, 43210
Site Reference ID/Investigator# 83739
Danbury, Connecticut, 06810
Site Reference ID/Investigator# 83723
Durham, North Carolina, 27710
Site Reference ID/Investigator# 89180
Fort Wayne, Indiana, 46804
Site Reference ID/Investigator# 87720
Gainesville, Florida, 32610
Site Reference ID/Investigator# 92413
Gastonia, North Carolina, 28054
Site Reference ID/Investigator# 83750
Grand Blanc, Michigan, 48439
Site Reference ID/Investigator# 101942
Indianapolis, Indiana, 46237
Site Reference ID/Investigator# 83746
Jacksonville, Florida, 32207
Site Reference ID/Investigator# 83733
Jacksonville, Florida, 32216
Site Reference ID/Investigator# 83730
Knoxville, Tennessee, 37923
Site Reference ID/Investigator# 85917
Lexington, Kentucky, 40536
Site Reference ID/Investigator# 91814
Madison, Wisconsin, 53792
Site Reference ID/Investigator# 101876
Memphis, Tennessee, 38120
Site Reference ID/Investigator# 87739
Milwaukee, Wisconsin, 53215
Site Reference ID/Investigator# 83722
New York, New York, 10032
Site Reference ID/Investigator# 93673
Newark, New Jersey, 07102
Site Reference ID/Investigator# 91253
Omaha, Nebraska, 68198-2315
Site Reference ID/Investigator# 83747
Petoskey, Michigan, 49770
Site Reference ID/Investigator# 83734
Pittsburgh, Pennsylvania, 15232
Site Reference ID/Investigator# 91693
Portland, Oregon, 97225
Site Reference ID/Investigator# 83725
Richmond, Virginia, 23225
Site Reference ID/Investigator# 83744
Royal Oak, Michigan, 48073
Site Reference ID/Investigator# 85913
Saint Paul, Minnesota, 55102
Site Reference ID/Investigator# 89182
Springfield, Oregon, 97447
Site Reference ID/Investigator# 96455
St Louis, Missouri, 63131
Site Reference ID/Investigator# 87714
Tacoma, Washington, 98405
Site Reference ID/Investigator# 89178
Tampa, Florida, 33613
Site Reference ID/Investigator# 83738
Toledo, Ohio, 43606
Site Reference ID/Investigator# 87733
Winston-Salem, North Carolina, 27103
Denmark3 sites
Site Reference ID/Investigator# 94956
Aarhus N, DK-8200
Site Reference ID/Investigator# 109295
Copenhagen O, 2100
Site Reference ID/Investigator# 94955
Odense C, 5000
About this study
Official title: A Phase 2b, Randomized, Double-Blind,Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery
This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.
- Conditions
- Acute Kidney Injury
- Being tested
- ABT-719, Placebo
- Keywords
- GFR, Acute Kidney Injury, High Risk cardiac surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-719Drug
1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
PlaceboDrug
Placebo infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 ABT-719 lower dose | Experimental | Not described Receives: Drug: ABT-719 |
| Arm 2 ABT-719 intermediate dose | Experimental | Not described Receives: Drug: ABT-719 |
| Arm 3 ABT-719 higher dose | Experimental | Not described Receives: Drug: ABT-719 |
| Arm 4 placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients developing acute kidney injury based on the Acute Kidney Injury Network (AKIN) scoring criteria by comparing the ABT-719 dose groups versus placebo group.
Measured: Up through Day 7
Secondary outcomes (5)
Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in estimated glomerular filtration rate or measured glomerular filtration rate
Measured: Up through Day 90
Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in serum creatinine based estimated glomerular filtration rate (GFR)
Measured: Up through Day 60
Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model
Measured: Up through Day 7
Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model
Measured: Up through Day 7
Changes from baseline (defined as within 24 hours of day 0) in serum creatinine (SCr) and S-Cystatin C at all study visits from baseline to Day 90
Measured: Up through Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Eldred, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777165
- Sponsor's protocol ID
- M13-796
- Other IDs
- 2012-003942-33
- Status last verified
- Jul 2021
- First submitted
- 24 Jan 2013
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McCullough PA, Bennett-Guerrero E, Chawla LS, Beaver T, Mehta RL, Molitoris BA, Eldred A, Ball G, Lee HJ, Houser MT, Khan S. ABT-719 for the Prevention of Acute Kidney Injury in Patients Undergoing High-Risk Cardiac Surgery: A Randomized Phase 2b Clinical Trial. J Am Heart Assoc. 2016 Aug 20;5(8):e003549. doi: 10.1161/JAHA.116.003549.
PubMed 27543797
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind,Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01777165
- Acronym / sponsor ID
- M13-796
- Conditions
- Acute Kidney Injury
- Keywords
- GFR, Acute Kidney Injury, High Risk cardiac surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 ABT-719 lower dose | Experimental | Drug: ABT-719 |
| Arm 2 ABT-719 intermediate dose | Experimental | Drug: ABT-719 |
| Arm 3 ABT-719 higher dose | Experimental | Drug: ABT-719 |
| Arm 4 placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must be male or female, age greater than or equal to 18 years old.
- Subjects must have stable renal function, per Investigator discretion and no known increase in serum creatinine of greater than or equal to 0.3 mg during the preceding 4 weeks.
- Subjects with estimated glomerular filtration rate less than or equal to 60 mL/min/1.73 m2 who require intravascular iodinated contrast within 48 hours of the day of surgery, will only be included if there is no known serum creatinine increase greater than or equal to 0.3 mg.
- Subjects must be undergoing a pre-defined on-pump cardiac surgery meeting one of the following acute kidney injury risk factors:
- Subject is undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
Key exclusion criteria (5 listed)
- Has an eGFR less than or equal to 15 mL/min/1.73 m2.
- Cardiac surgery to be performed without cardiopulmonary bypass.
- Has ongoing sepsis or history of sepsis within the last 2 weeks or untreated diagnosed infection prior to Screening visit. Sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension.
- Has known or documented RIFLE "R" or AKIN "Stage I" within the previous 4 weeks.
- Recently received (within the last 10 weeks) or is anticipated to receive chemotherapy which can interfere with kidney function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-7191 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose | Drug | Arm 1 ABT-719 lower dose, Arm 2 ABT-719 intermediate dose, Arm 3 ABT-719 higher dose |
| PlaceboPlacebo infusion | Drug | Arm 4 placebo |
Primary outcome
Number of patients developing acute kidney injury based on the Acute Kidney Injury Network (AKIN) scoring criteria by comparing the ABT-719 dose groups versus placebo group.
Time frame: Up through Day 7
5 secondary outcomes
Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in estimated glomerular filtration rate or measured glomerular filtration rate
Time frame: Up through Day 90
Proportion of subjects developing at least one of the composite events: death, needing renal replacement therapy, or having greater than or equal to 25 percent reduction in serum creatinine based estimated glomerular filtration rate (GFR)
Time frame: Up through Day 60
Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model
Time frame: Up through Day 7
Proportion of subjects developing AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) model
Time frame: Up through Day 7
Changes from baseline (defined as within 24 hours of day 0) in serum creatinine (SCr) and S-Cystatin C at all study visits from baseline to Day 90
Time frame: Up through Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Results publication: PubMed 27543797McCullough PA, Bennett-Guerrero E, Chawla LS, Beaver T, Mehta RL, Molitoris BA, Eldred A, Ball G, Lee HJ, Houser MT, Khan S. ABT-719 for the Prevention of Acute Kidney Injury in Patients Undergoing High-Risk Cardiac Surgery: A Randomized Phase 2b Clinical Trial. J Am Heart Assoc. 2016 Aug 20;5(8):e003549. doi: 10.1161/JAHA.116.003549.
Related trials for Acute Kidney Injury
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Eldred, MD study director
AbbVie
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-719 in people with Acute Kidney Injury, run by AbbVie at 41 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients developing acute kidney injury based on the Acute Kidney Injury Network (AKIN) scoring criteria by comparing the ABT-719 dose groups versus placebo group. (time frame: Up through Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01777165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.