Cardiothoracic SurgeryPhase 2NCT01897519
A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Surgery
A Phase 2 study testing ABT-719 in people with Cardiothoracic Surgery and Vascular Surgery, run by AbbVie at 23 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiothoracic Surgery, Vascular Surgery
- 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
- 56 participants
- Where
- 23 sitesin 2 countries
- Study dates
- May 2013to May 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
- Patients undergoing high risk major surgery in subjects with cardiovascular disease who are at risk of AKI.
Who cannot join
- Ongoing or recent history of sepsis
- Has recent documented acute kidney injury.
- Subject is scheduled to have a total or partial nephrectomy.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States20 sites
Site Reference ID/Investigator# 103356
Boston, Massachusetts, 02115
Site Reference ID/Investigator# 96303
Boston, Massachusetts, 02135
Site Reference ID/Investigator# 108255
Charlottesville, Virginia, 22908
Site Reference ID/Investigator# 102020
Cleveland, Ohio, 44195
Site Reference ID/Investigator# 103355
Columbus, Ohio, 43210
Site Reference ID/Investigator# 96296
Durham, North Carolina, 27710
Site Reference ID/Investigator# 96302
Fort Wayne, Indiana, 46804
Site Reference ID/Investigator# 96295
Gainesville, Florida, 32610
Site Reference ID/Investigator# 96997
Grand Blanc, Michigan, 48439
Site Reference ID/Investigator# 101961
Indianapolis, Indiana, 46237
Site Reference ID/Investigator# 96778
Jacksonville, Florida, 32207
Site Reference ID/Investigator# 102019
Memphis, Tennessee, 38120
Site Reference ID/Investigator# 96300
Milwaukee, Wisconsin, 53215
Site Reference ID/Investigator# 96996
New York, New York, 10032
Site Reference ID/Investigator# 97878
Petoskey, Michigan, 49770
Site Reference ID/Investigator# 97556
Pittsburgh, Pennsylvania, 15232
Site Reference ID/Investigator# 103316
Providence, Rhode Island, 02903
Site Reference ID/Investigator# 99377
Royal Oak, Michigan, 48073
Site Reference ID/Investigator# 96301
Tampa, Florida, 33613
Site Reference ID/Investigator# 99317
West Orange, New Jersey, 07052
Denmark3 sites
Site Reference ID/Investigator# 105755
Aarhus N, 8200
Site Reference ID/Investigator# 105757
Kolding, 6000
Site Reference ID/Investigator# 105756
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 Major Surgery
This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.
- Conditions
- Cardiothoracic Surgery, Vascular Surgery
- Being tested
- Placebo, ABT-719
- Keywords
- High risk surgery, Acute Kidney Injury
- 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.
PlaceboDrug
Placebo infusion
ABT-719Drug
Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 lower dose ABT-719 | Experimental | Not described Receives: Drug: ABT-719 |
| Arm 2 intermediate dose ABT-719 | Experimental | Not described Receives: Drug: ABT-719 |
| Arm 3 high dose ABT-719 | 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.
Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7.
Measured: Day 0 to Day 7
Secondary outcomes (4)
Proportion of subjects that develop composite event at 90 days post surgery
Develop at least one of the composite events: death, needing renal replacement therapy during the 90-day post operative period, or having a greater than 25% reduction in estimated or measured glomerular filtration rate.
Measured: 90 Day
Proportion of subjects that develop a composite event at 60 days post surgery
Develop at least one of the composite events: death, needing renal replacement therapy during the 60-day post operative period, or having a greater than 25% reduction in estimated or measured glomerular filtration rate.
Measured: 60 Days
Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria
Measured: Day 7
Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Topline results from study M13-796 showed an overall lack of efficacy. There were no safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiothoracic SurgeryStudies 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
- 56 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
- NCT01897519
- Sponsor's protocol ID
- M13-958
- Other IDs
- 2012-005710-19
- Status last verified
- Jun 2014
- First submitted
- 10 May 2013
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. 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 Major Surgery
- ClinicalTrials.gov ID
- NCT01897519
- Acronym / sponsor ID
- M13-958
- Conditions
- Cardiothoracic Surgery, Vascular Surgery
- Keywords
- High risk surgery, Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Topline results from study M13-796 showed an overall lack of efficacy. There were no safety concerns.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Jul 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 patients undergoing high risk major 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 lower dose ABT-719 | Experimental | Drug: ABT-719 |
| Arm 2 intermediate dose ABT-719 | Experimental | Drug: ABT-719 |
| Arm 3 high dose ABT-719 | 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 (1 listed)
- Patients undergoing high risk major surgery in subjects with cardiovascular disease who are at risk of AKI.
Key exclusion criteria (3 listed)
- Ongoing or recent history of sepsis
- Has recent documented acute kidney injury.
- Subject is scheduled to have a total or partial nephrectomy.
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 |
|---|---|---|
| PlaceboPlacebo infusion | Drug | Arm 4 Placebo |
| ABT-719Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose | Drug | Arm 1 lower dose ABT-719, Arm 2 intermediate dose ABT-719, Arm 3 high dose ABT-719 |
Primary outcome
Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Time frame: Day 0 to Day 7
Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7.
4 secondary outcomes
Proportion of subjects that develop composite event at 90 days post surgery
Time frame: 90 Day
Proportion of subjects that develop a composite event at 60 days post surgery
Time frame: 60 Days
Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria
Time frame: Day 7
Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria
Time frame: Day 7
Results and safety
The study was stopped early (reason given: Topline results from study M13-796 showed an overall lack of efficacy. There were no safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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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
23 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 Cardiothoracic Surgery and Vascular Surgery, run by AbbVie at 23 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 was stopped early (reason given: Topline results from study M13-796 showed an overall lack of efficacy. There were no safety concerns.). Results are not available in the source record.
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?
Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) (time frame: Day 0 to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2014.