Suramin for Acute Kidney Injury

Not currently recruiting at 11 trial locations

Overseen By Jeremy Whitson

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rediscovery Life Sciences

Must not be taking: Vasopressors, Warfarin

Disqualifiers: Dialysis, Renal transplant, Hepatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests suramin, a medication, to determine if it can prevent acute kidney injury (AKI) from worsening. The goal is to stop AKI from progressing to more severe kidney problems that might require dialysis. Participants will receive either suramin or a placebo (a harmless pill with no medication) to compare results. Suitable candidates have AKI with noticeable changes in kidney function but have not yet needed dialysis or had a kidney transplant. As a Phase 2 trial, this research measures suramin's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on warfarin, you must be on stable long-term therapy. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that suramin is likely to be safe for humans?

Research has shown that suramin has potential to protect kidneys. In one study, suramin prevented kidney damage caused by cisplatin, a drug known to harm kidneys. This suggests suramin might generally help protect kidneys.

The current study is in an early stage, typically used to assess how well people tolerate a treatment and to identify any side effects. Although suramin is being tested for acute kidney injury (AKI), it has been used previously for other health issues. Its past use suggests it might be safe, but further research is needed to confirm this.

Overall, these findings suggest suramin could be safe, but monitoring for side effects remains important as more studies are conducted. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Suramin is unique because it offers a new approach to treating acute kidney injury. Most treatments for this condition focus on managing symptoms and supporting kidney function but don't directly address underlying causes. Suramin is different as it targets the root cellular stress and inflammation that contribute to kidney damage. Researchers are excited about Suramin because of its potential to reduce damage and improve recovery, which could lead to better outcomes for patients with acute kidney injury.

What evidence suggests that suramin might be an effective treatment for acute kidney injury?

Research has shown that suramin, which participants in this trial may receive, might help treat sudden kidney injury, known as acute kidney injury (AKI). Studies have found that suramin can improve kidney function after AKI caused by factors such as certain chemotherapy drugs or muscle breakdown. In these studies, suramin protected the kidneys and aided recovery by repairing kidney cells and reducing damage. This suggests that suramin could prevent AKI from worsening and requiring more serious treatments, like advanced kidney disease or dialysis. These findings offer hope that suramin could be a promising treatment for AKI. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

Adults with early-stage acute kidney injury (AKI) who haven't responded to a diuretic called furosemide are eligible. They must not have severe liver issues, be on multiple blood pressure medications, or have certain infections like HIV or COVID-19. A negative pregnancy test is required for women of childbearing age.

Inclusion Criteria

If female of childbearing potential, must have a negative pregnancy test at Screening

Is capable of providing informed consent as described in this protocol.

Your kidneys are not working well, and your blood test shows that a specific substance called creatinine has increased by a certain amount within 48 hours.

Exclusion Criteria

You have severe liver disease or signs of liver and kidney problems.

Unwilling to participate in follow-up phone surveys up to 180 days post-treatment

Are enrolled in another interventional research study or have participated in another interventional study within 14 days of Screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single 3.0 mg/kg infusion of suramin or placebo

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Suramin

Trial Overview

The study is testing Suramin against a placebo in patients with AKI to see if it can prevent worsening to Stage III AKI or the need for dialysis. Participants will be randomly assigned to receive either Suramin or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Suramin Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rediscovery Life Sciences

Lead Sponsor

Trials

1

Recruited

70+

Published Research Related to This Trial

Currently, there are no specific therapies approved for the prevention or treatment of acute kidney injury (AKI), and traditional care remains largely supportive.

Recent research has identified various potential compounds targeting different pathways involved in AKI, such as oxidative stress and inflammation, which are now entering early-phase clinical trials, showing promise for future treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New drugs for acute kidney injury. Côté, JM., Murray, PT., Rosner, MH.[2021]

Acute kidney injury (AKI) can lead to a range of outcomes, from complete recovery to chronic kidney disease or end-stage renal disease, highlighting the need for better understanding of the factors influencing these outcomes.

Recovery from AKI is a modifiable event, suggesting that targeted therapies and monitoring tools are essential for improving renal recovery and identifying patients at high risk for adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical determinants of renal recovery. Godin, M., Macedo, E., Mehta, RL.[2015]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04496596

Study of Suramin in Subjects With Furosemide-Resistant AKI

This is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4877945/

Suramin protects from cisplatin-induced acute kidney injury

DISCUSSION. Studies have shown that treatment with suramin after the onset of AKI improved recovery of renal function after renal ischemia-reperfusion and ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022356524181621

Recovery from Glycerol-Induced Acute Kidney Injury Is ...

In this study, we examined the efficacy and mechanism(s) of suramin in promoting recovery from glycerol-induced AKI, a model of rhabdomyolysis-induced AKI.

4.

stemcellres.biomedcentral.com

stemcellres.biomedcentral.com/articles/10.1186/scrt225

Improving outcomes of acute kidney injury using mouse renal ...

These results suggest that MRPC, in particular MRPC/EPO or MRPC/suramin, promote renal repair after injury and may be a promising therapeutic strategy.

5.

ir.library.louisville.edu

ir.library.louisville.edu/etd/2217/

Suramin protects from cisplatin-induced acute kidney injury.

Our data indicates that suramin protects the kidney from injury by decreasing cisplatininduced decreases in kidney function. Renal histology indicated that ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3310704/

Recovery from Glycerol-Induced Acute Kidney Injury Is ...

Suramin Increases Urinary and Renal NGAL Levels after Glycerol-Induced AKI. Urinary NGAL in glycerol-treated rats was elevated compared with that in control ...

7.

withpower.com

withpower.com/trial/phase-3-acute-kidney-injury-10-2020-0d541

Suramin for Acute Kidney Injury · Info for Participants

Trial Overview The study is testing Suramin against a placebo in patients with AKI to see if it can prevent worsening to Stage III AKI or the need for dialysis.