Recent Updates
Recently added Catalysts

ABT-719

Phase 2

Acute Kidney Injury | Small molecule | Nephrology |AbbVie Inc.|Last Updated: Jul 7, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

ABT-719 · 1 trial · 1 indication

Phase 2 1
NCT01777165A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac SurgeryAcute Kidney Injury
COMPLETED240 Analytics
PHASE2COMPLETED
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
Acute Kidney InjuryUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
Up through Day 7

Secondary Endpoints

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
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)
Up through Day 60
Proportion of subjects developing AKI as defined by the Risk, Injury, Failure, Loss, or ESRD (RIFLE) model
Up through Day 7
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1 ABT-719 lower doseEXPERIMENTAL -
Arm 2 ABT-719 intermediate doseEXPERIMENTAL -
Arm 3 ABT-719 higher doseEXPERIMENTAL -
Arm 4 placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ABT-719DRUG1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
PlaceboDRUGPlacebo infusion
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * 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 estimat...

Countries:United StatesDenmark
Unlock Eligibility Criteria

Frequently asked questions about ABT-719

What is ABT-719 used for?

ABT-719 is an investigational small molecule being studied for the prevention of acute kidney injury in patients undergoing high-risk cardiac surgery. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does ABT-719 target?

The molecular target of ABT-719 has not been disclosed in available information. The drug is being evaluated for its potential to prevent acute kidney injury, but its specific mechanism of action is not publicly detailed.

Who makes ABT-719?

ABT-719 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is ABT-719 in?

ABT-719 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it is not yet approved for commercial use.

What clinical trials is ABT-719 in?

ABT-719 has one completed Phase 2 trial, NCT01777165, which evaluated multiple dosing regimens for the prevention of acute kidney injury in subjects undergoing high-risk cardiac surgery. The trial enrolled 240 participants in the United States and Denmark.

Is ABT-719 the same as any other drug?

No alternative names for ABT-719 have been reported. The drug is identified solely by its code name ABT-719 in clinical trial registries and available information.