Acute Kidney InjuryPhase 2NCT05879432
LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery
A Phase 2 study testing LSALT Peptide in people with Acute Kidney Injury and Cardiac Surgery, run by Arch Biopartners Inc. at 9 sites in 2 countries.
Trial summary
To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria: 1. Increase in baseline (pre-surgery) serum creatinine (SCr) by ≥26.5 μmol/L (≥0.3 mg/dL) within 7 days; OR 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cardiac Surgery
- What is being tested?
- LSALT Peptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 8 Mar 2024to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male and female ≥ 18 years of age.
- Scheduled for a non-emergent coronary and/or valve surgery procedure requiring on-pump cardiopulmonary bypass including but not limited to:
- Coronary artery bypass graft (CABG) alone
- CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- Aortic valve replacement or repair alone, with or without aortic root repair
- Mitral, tricuspid, or pulmonic valve replacement or repair alone
Show all 19Show fewer
- Simultaneous replacement of several cardiac valves.
- Have the following AKI risk factors:
- CKD Stage 3 (CKD-EPI eGFR ≥ 30 and < 60 mL/min/1.73 m2) and ONE or more of the following additional risk factors OR
- CKD Stage 2 (CKD-EPI eGFR ≥ 60 and < 90 mL/min/1.73 m2) and ONE or more of the following additional risk factors:
- Age ≥ 75 years;
- Combined valve \& coronary artery surgery;
- Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive techniques;
- Urinary (TIMP-2 x IGFBP7) > 0.3
- Diabetes mellitus
- Hypertension
- Hyperlipidemia
- Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control throughout the study and for at least 1 day following the end of study and have a negative urine pregnancy test at the Screening visit. A WCBP is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or the implant. In patients who are not sexually active, abstinence is an acceptable form of birth control and urine will be tested per protocol. Women who are of nonchild-bearing potential, i.e., post-menopause, must have this condition captured in their medical history. Pregnant women and nursing mothers are excluded from this study.
- Patient or Legally Authorized Representative (LAR) is available and willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.
Who cannot join
- The presence of AKI (KDIGO criteria) at the time of randomization
- Off-pump cardiac surgery
- Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature < 28°C (82.4° F)
- Severe chronic kidney disease: CKD-eGFR < 30 mL/min/1.73 m2) OR requiring dialysis
- Imminent or recent surgery for aortic dissection
- Surgery to correct a major congenital heart defect (e.g., Tetralogy of Fallot, transposition of the great vessels, single ventricle, or Ebstein's anomaly. Bicuspid aortic valve is not considered a congenital heart defect)
Show all 13Show fewer
- Known history of active cancer which may interfere with interpretation of the results of this study
- Known or suspected sepsis at time of screening
- Pregnancy or lactation
- Known hypersensitivity to the study drug or any of its excipients
- Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug and throughout the study
- Any disease processes or confounding variables that would inappropriately alter the outcome of the study in the opinion of the investigator
- Inability to comply with the requirements of the study protocol.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
David Luke contact
9 sites in 2 countries
Turkey (Türkiye)5 sites
- Completed
Kocaeli University, Faculty of Medicine Practices and Research Hospital
İzmit, Kocaeli, 41001
- Completed
Sütçü İmam University, Faculty of Medicine
Kahramanmaraş, Onikişubat, 46040
- Completed
Kosuyolu High Specialization Training and Research Hospital
Kartal, Istanbul, 34865
- Completed
Erciyes University, Faculty of Medicine - Semiha Kibar Organ Transplant & Dialysis Hospital
Melikgazi, Kayseri, 38030
- Completed
Gazi University
Yenimahalle, Ankara, 06560
Canada4 sites, 4 recruiting
- Recruiting
Cumming School of Medicine & Libin Cardiovascular Centre, University of Calgary
Calgary, Alberta, T2N 4N1
Alexander J Gregory, 403 944 1539, alex.gregory@albertahealthservices.ca
- Recruiting
Royal Columbian Hospital
New Westminster, British Columbia, V3L 0A2
Derek Gunning, 604-522-6800
- Recruiting
Unity Health Toronto, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
David Mazer, 416 864 6060 ext. 5825, david.mazer@unityhealth.to
- Recruiting
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 1L7
Keyvan Karkouti, 416 340 3698, keyvan.karkouti@uhn.ca
About this study
Official title: Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT Peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery
To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria:
- Increase in baseline (pre-surgery) serum creatinine (SCr) by ≥26.5 μmol/L (≥0.3 mg/dL) within 7 days; OR
- Increase in baseline SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the first 7 days following surgery; OR
- Urine output < 0.5 mL/kg/h for >6 hours.
Read the detailed description
This study is a randomized, double-blind, multicenter interventional study to assess safety and efficacy of LSALT peptide versus placebo (matching drug-free saline) in patients undergoing on-pump cardiac surgery. Patients will be followed for safety and efficacy up to Day 28 (EOS), with Day 1 being the day of randomization of study drug administered at least 1 hour prior to induction of anesthesia.
A total of 240 patients will be included in the study, 120 patients each will be randomized to LSALT peptide or placebo. This study will be double-blinded with only the pharmacist at the site unblinded for the purpose of preparing drug/placebo for injection.
All subjects will undergo tests during the Screening period (window days -14 to Day 1). After satisfying all inclusion and exclusion criteria, the patient will be randomized equally to the following study arms:
- LSALT peptide 10 mg IV administered over 1 hour twice daily, every 12 ± 1hour, for 5 days
- Placebo IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days
Study treatment will be initiated pre-operatively on Day 1 and continued for 5 days. Physical examinations, vital signs and urine output will be recorded daily throughout the treatment period and on days 6 and 7. Adverse events will be recorded daily throughout the treatment period, on Days 6, 7, and 28 EOS (Day 28). Kidney function (serum creatinine, serum cystatin C, and BUN), clinical laboratory tests, and other biomarkers will be assessed at baseline (prior to initiation of study drug) and monitored daily throughout the treatment period, on Days 6, 7, and EOS (Day 28). All patients will be maintained on the standard of care (SOC) as per institutional guidelines. Thus, SOC will be followed in each patient with the addition of LSALT peptide or placebo.
Subjects will be followed until EOS (Day 28 ± 3 days) to assess renal function as discussed above.
An independent Data and Safety Monitoring Board (DSMB) will evaluate patients on a continuing basis for primarily safety assessments. Per the DSMB Charter, the DSMB will meet at least monthly if not more frequently based upon enrollment throughout the study period.
- Conditions
- Acute Kidney Injury, Cardiac Surgery
- Being tested
- LSALT Peptide, Placebo
- 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.
LSALT PeptideDrug
Also called Metablok
LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity, potentially minimizing off-target or other adverse effects. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
PlaceboDrug
0.9% saline solution
| Study group | Role | What they receive |
|---|---|---|
| LSALT Peptide | Experimental | LSALT peptide 10 mg IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days Receives: Drug: LSALT Peptide |
| Placebo | Placebo comparator | Placebo IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria
- Increase in baseline (pre-surgery) serum creatinine (SCr) by ≥26.5 μmol/L (≥0.3 mg/dL) within 7 days; OR
- Increase in baseline SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the first 7 days following surgery; OR
- Urine output < 0.5 mL/kg/h for >6 hours.
Measured: 7 days
Secondary outcomes (14)
Maximum severity of AKI per patient between treatment groups
- Stage 1: SCr 1.5 - 1.9 times baseline OR ≥26.5 μmol/L (≥0.3 mg/dL) increase OR urine output <0.5 mL/kg/hr for 6-12 hours
- Stage 2: SCr 2.0 - 2.9 times baseline OR urine output <0.5 mL/kg/h for ≥ 12 hours
- Stage 3: SCr ≥3.0 times baseline OR increase in SCr of ≥26.5 μmol/L (≥0.3 mg/dL) to ≥353.6 μmol/L (≥4.0 mg/dL) OR initiation of renal replacement therapy (RRT) OR urine output <0.3 mL/kg/h for ≥24 hours OR anuria for ≥12 hours.
Measured: 7 days
Time to mild, moderate, and severe AKI per patient between treatment groups
Measured: 7 days
Need for RRT within the first 7 days following surgery
Measured: 7 days
Need for RRT at any time during the 28-day study
Measured: 28 days
Duration of AKI at 28 days (EOS)
Duration of AKI is defined as the number of days from start of AKI per KDIGO criteria to onset of resolution
Measured: 28 days
Kidney function (SCr, eGFR) at 28 days (EOS)
Measured: 28 days
28-day all-cause mortality
Measured: 28 days
Composite of death, need for RRT, and/or persistent impaired renal function from baseline (MAKE [major adverse kidney event] criteria) at Day 28 (EOS)
Measured: 28 days
ICU length of stay (in days)
Measured: 28 days
Hospitalization length of stay (in days)
Measured: 28 days
Incidence of new-onset lung or liver disorders following surgery
Measured: 28 days
Change in baseline serum cystatin C, serum NGAL, serum IP-10, serum IL-1beta, serum IL-6, and serum IL-18 biomarker levels
Measured: 28 days
Changes in urinary TIMP-2 and IGFBP7 biomarker and serum NGAL, AGT, and IL-18 biomarker levels
Biomarkers will be measured at baseline and days 1, 3, 5, and 7
Measured: 7 days
Development of serum anti-drug antibodies levels throughout the study
Anti-drug antibodies will be measured at baseline (Day 1 prior to the first dose of study medication) and at days 1, 2, 3, 4, 5 and day 28 (EOS)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start8 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arch Biopartners Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879432
- Sponsor's protocol ID
- AB003
- Status last verified
- Jun 2026
- First submitted
- 18 May 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT Peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05879432
- Acronym / sponsor ID
- AB003
- Conditions
- Acute Kidney Injury, Cardiac Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Arch Biopartners Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 May 2023 (actual)
- 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.
To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria:
- Increase in baseline (pre-surgery) serum creatinine (SCr) by ≥26.5 μmol/L (≥0.3 mg/dL) within 7 days; OR
- Increase in baseline SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the first 7 days following surgery; OR
- Urine output < 0.5 mL/kg/h for >6 hours.
Detailed description
This study is a randomized, double-blind, multicenter interventional study to assess safety and efficacy of LSALT peptide versus placebo (matching drug-free saline) in patients undergoing on-pump cardiac surgery. Patients will be followed for safety and efficacy up to Day 28 (EOS), with Day 1 being the day of randomization of study drug administered at least 1 hour prior to induction of anesthesia.
A total of 240 patients will be included in the study, 120 patients each will be randomized to LSALT peptide or placebo. This study will be double-blinded with only the pharmacist at the site unblinded for the purpose of preparing drug/placebo for injection.
All subjects will undergo tests during the Screening period (window days -14 to Day 1). After satisfying all inclusion and exclusion criteria, the patient will be randomized equally to the following study arms:
- LSALT peptide 10 mg IV administered over 1 hour twice daily, every 12 ± 1hour, for 5 days
- Placebo IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days
Study treatment will be initiated pre-operatively on Day 1 and continued for 5 days. Physical examinations, vital signs and urine output will be recorded daily throughout the treatment period and on days 6 and 7. Adverse events will be recorded daily throughout the treatment period, on Days 6, 7, and 28 EOS (Day 28). Kidney function (serum creatinine, serum cystatin C, and BUN), clinical laboratory tests, and other biomarkers will be assessed at baseline (prior to initiation of study drug) and monitored daily throughout the treatment period, on Days 6, 7, and EOS (Day 28). All patients will be maintained on the standard of care (SOC) as per institutional guidelines. Thus, SOC will be followed in each patient with the addition of LSALT peptide or placebo.
Subjects will be followed until EOS (Day 28 ± 3 days) to assess renal function as discussed above.
An independent Data and Safety Monitoring Board (DSMB) will evaluate patients on a continuing basis for primarily safety assessments. Per the DSMB Charter, the DSMB will meet at least monthly if not more frequently based upon enrollment throughout the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSALT Peptide | Experimental | Drug: LSALT PeptideLSALT peptide 10 mg IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male and female ≥ 18 years of age.
- Scheduled for a non-emergent coronary and/or valve surgery procedure requiring on-pump cardiopulmonary bypass including but not limited to:
- Have the following AKI risk factors:
- Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control throughout the study and for at least 1 day following the end of study and have a negative urine pregnancy test at the Screening visit. A WCBP is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or the implant. In patients who are not sexually active, abstinence is an acceptable form of birth control and urine will be tested per protocol. Women who are of nonchild-bearing potential, i.e., post-menopause, must have this condition captured in their medical history. Pregnant women and nursing mothers are excluded from this study.
- Patient or Legally Authorized Representative (LAR) is available and willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.
Key exclusion criteria (13 listed)
- The presence of AKI (KDIGO criteria) at the time of randomization
- Off-pump cardiac surgery
- Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature < 28°C (82.4° F)
- Severe chronic kidney disease: CKD-eGFR < 30 mL/min/1.73 m2) OR requiring dialysis
- Imminent or recent surgery for aortic dissection
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 |
|---|---|---|
| LSALT PeptideAlso: MetablokLSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity, potentially minimizing off-target or other adverse effects. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver. | Drug | LSALT Peptide |
| Placebo0.9% saline solution | Drug | Placebo |
Primary outcome
To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Time frame: 7 days
1. Increase in baseline (pre-surgery) serum creatinine (SCr) by ≥26.5 μmol/L (≥0.3 mg/dL) within 7 days; OR 2. Increase in baseline SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the first 7 days following surgery; OR 3. Urine output < 0.5 mL/kg/h for >6 hours.
14 secondary outcomes
Maximum severity of AKI per patient between treatment groups
Time frame: 7 days
Time to mild, moderate, and severe AKI per patient between treatment groups
Time frame: 7 days
Need for RRT within the first 7 days following surgery
Time frame: 7 days
Need for RRT at any time during the 28-day study
Time frame: 28 days
Duration of AKI at 28 days (EOS)
Time frame: 28 days
Kidney function (SCr, eGFR) at 28 days (EOS)
Time frame: 28 days
28-day all-cause mortality
Time frame: 28 days
Composite of death, need for RRT, and/or persistent impaired renal function from baseline (MAKE [major adverse kidney event] criteria) at Day 28 (EOS)
Time frame: 28 days
ICU length of stay (in days)
Time frame: 28 days
Hospitalization length of stay (in days)
Time frame: 28 days
Incidence of new-onset lung or liver disorders following surgery
Time frame: 28 days
Change in baseline serum cystatin C, serum NGAL, serum IP-10, serum IL-1beta, serum IL-6, and serum IL-18 biomarker levels
Time frame: 28 days
Changes in urinary TIMP-2 and IGFBP7 biomarker and serum NGAL, AGT, and IL-18 biomarker levels
Time frame: 7 days
Development of serum anti-drug antibodies levels throughout the study
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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.
David Luke contact
9 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 LSALT Peptide in people with Acute Kidney Injury and Cardiac Surgery, run by Arch Biopartners Inc. at 9 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 19 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Turkey (Türkiye), Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Muruve (+1 647 428 7031, rm@archbiopartners.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria (time frame: 7 days). 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 12 Jun 2026.