240 Participants Needed

LSALT Peptide for Acute Kidney Injury During Cardiac Surgery

Recruiting at 8 trial locations
RM
DL
Overseen ByDavid Luke
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Arch Biopartners Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug LSALT Peptide for treating acute kidney injury during cardiac surgery?

Research on similar peptides, like Elabela, shows they can protect against kidney injury by reducing inflammation and cell damage in animal models. This suggests that LSALT Peptide might also help protect the kidneys during cardiac surgery.12345

What makes LSALT Peptide unique for treating acute kidney injury during cardiac surgery?

LSALT Peptide is unique because it targets inflammation and tissue damage specifically during cardiac surgery, which is a common cause of acute kidney injury (AKI). Unlike other treatments, it may offer a novel approach by focusing on reducing inflammation and protecting kidney tissues during the surgical process.12567

What is the purpose of this trial?

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; OR2. Increase in baseline SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the first 7 days following surgery; OR3. Urine output \< 0.5 mL/kg/h for \>6 hours.

Eligibility Criteria

This trial is for adults over 18 who are undergoing on-pump cardiac surgery, such as bypass grafts or valve replacements. It's specifically for those with moderate chronic kidney disease (CKD Stage 3) and additional risk factors like diabetes or reduced heart function, or simply being aged 75 years or older.

Inclusion Criteria

Have the following AKI risk factors: CKD Stage 3 (CKD-EPI eGFR ≥ 30 and < 60 mL/min/1.73 m2) and ONE of the following additional risk factors (below; excluding age ≥ 75 years) OR CKD Stage 2 (CKD-EPI eGFR ≥ 60 and < 90 mL/min/1.73 m2) and TWO 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, Diabetes mellitus on treatment, Albuminuria (random urine albumin:creatinine ratio >30 mg/mmol), 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
I am scheduled for heart surgery that includes using a heart-lung machine.

Exclusion Criteria

I currently have acute kidney injury.
I might have an infection in my blood.
Pregnancy or lactation
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive LSALT peptide or placebo intravenously twice daily for 5 days

5 days
Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including kidney function assessments

28 days
Regular monitoring (in-person)

Treatment Details

Interventions

  • LSALT Peptide
Trial Overview The study tests if LSALT Peptide can prevent or lessen acute kidney injury after heart surgery compared to a placebo. The main measure is changes in serum creatinine levels or urine output according to the KDIGO criteria within the first week after surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LSALT PeptideExperimental Treatment1 Intervention
LSALT peptide 10 mg IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arch Biopartners Inc.

Lead Sponsor

Trials
4
Recruited
3,300+

Findings from Research

ELABELA (ELA) and its fragments, ELA32 and ELA11, show protective effects against renal ischemia-reperfusion injury by reducing DNA damage, inflammation, and apoptosis in kidney cells, indicating their potential as therapeutic candidates for acute kidney injury (AKI).
In mouse models, treatment with ELA32 or ELA11 significantly reduced renal fibrosis, inflammation, and dysfunction caused by ischemia-reperfusion injury, while a mutant form of ELA11 did not provide the same protective effects, highlighting the importance of the peptide's structure for its efficacy.
ELABELA and an ELABELA Fragment Protect against AKI.Chen, H., Wang, L., Wang, W., et al.[2018]
The Fc-ELA fusion protein showed significant renoprotective effects in mice with endotoxemia-induced acute kidney injury (AKI), improving kidney function and reducing inflammation after LPS treatment.
Treatment with Fc-ELA restored the expression of the kidney peptide hormone apela and reduced reactive oxygen species (ROS) production, indicating its potential as a therapeutic option for AKI.
Fc-Elabela fusion protein attenuates lipopolysaccharide-induced kidney injury in mice.Xu, F., Zhou, H., Wu, M., et al.[2020]
In a mouse model, the cyclic helical B-peptide (CHBP) significantly improved kidney function and reduced tissue damage caused by aristolochic acid (AA), as evidenced by decreased blood urea nitrogen and serum creatinine levels.
CHBP demonstrated its protective effects by reducing apoptosis and inflammation in the kidneys, likely through the inhibition of caspase-3 activation and the enhancement of anti-apoptotic proteins like bcl-2 and bcl-xl.
Protective effects of cyclic helix B peptide on aristolochic acid induced acute kidney injury.Zeng, Y., Zheng, L., Yang, Z., et al.[2018]

References

ELABELA and an ELABELA Fragment Protect against AKI. [2018]
Fc-Elabela fusion protein attenuates lipopolysaccharide-induced kidney injury in mice. [2020]
Protective effects of cyclic helix B peptide on aristolochic acid induced acute kidney injury. [2018]
Effects of human atrial natriuretic peptide in patients after coronary artery bypass surgery. [2019]
Cyclic Helix B Peptide in Preservation Solution and Autologous Blood Perfusate Ameliorates Ischemia-Reperfusion Injury in Isolated Porcine Kidneys. [2020]
Identifying Candidate Protein Markers of Acute Kidney Injury in Acute Decompensated Heart Failure. [2022]
Acute Kidney Injury Associated with Cardiac Surgery: a Comprehensive Literature Review. [2020]
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