EDG-7500 for Kidney Failure

Recruiting at 1 trial location

Overseen By Edgewise Therapeutics, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Edgewise Therapeutics, Inc.

Disqualifiers: Alcohol, Drug abuse, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 11 days

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called EDG-7500 to assess its behavior in the blood and its safety for individuals with varying levels of kidney function. Participants will be grouped based on mild, moderate, or severe kidney impairment or normal kidney function. The trial aims to understand how the drug might work differently for those with kidney issues. Individuals with stable kidney function, whether impaired or normal, and who have not recently undergone dialysis, might be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that EDG-7500 is likely to be safe for humans?

Research has shown that EDG-7500 was well-tolerated in early studies with healthy participants. In a previous study, participants did not experience significant side effects, suggesting it might be safe to use. However, this is the first trial to test EDG-7500 in individuals with kidney problems. As an early-phase study, there is limited information on how people with kidney issues might react. This trial aims to provide more insight into its safety for this specific group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney failure?

Researchers are excited about EDG-7500 because it offers a novel approach to treating kidney failure. Unlike standard treatments like dialysis or kidney transplants, which are invasive or limited by donor availability, EDG-7500 could potentially improve kidney function through a new mechanism of action. This treatment is being tested across various levels of renal impairment, including mild, moderate, and severe cases, suggesting it might be versatile and adaptable to different patient needs. If successful, EDG-7500 could provide a less invasive and more widely accessible option for patients suffering from kidney failure.

What evidence suggests that EDG-7500 might be an effective treatment for kidney failure?

Research shows that EDG-7500 is under investigation for its potential to treat kidney failure. The trial divides participants into different arms based on their renal impairment status: mild, moderate, or severe, along with a group of healthy volunteers. Early studies examine the drug's concentration in the blood after administration, which aids in understanding its metabolism. Although limited information from human studies exists, EDG-7500 is believed to target specific kidney functions that often malfunction. Initial signs suggest it could improve kidney health by addressing these issues. As more research results emerge, the treatment's effectiveness will become clearer. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with varying degrees of kidney function, from normal to impaired due to kidney failure. It aims to understand how a single dose of EDG-7500 behaves in their bodies and its safety profile.

Inclusion Criteria

QTcF interval ≤ 500 msec and has ECG findings considered normal or not clinically significant

Liver function test including ALT ≤ ULN, AST ≤ ULN, and total bilirubin ≤ 1.5 ULN

Blood pressure ≥ 90/40 mmHg and ≤ 150/95 mmHg

Exclusion Criteria

Diabetes confirmed with HbA1c > 8.5%

History of any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study

I have kidney problems ranging from mild to severe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of EDG-7500 and are monitored for pharmacokinetics and safety

11 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EDG-7500

Trial Overview The study tests the drug EDG-7500 by giving one dose to participants and then measuring its levels in the blood. The goal is to compare how well it's processed by those with different kidney health statuses.

How Is the Trial Designed?

Group I: Severe Renal Impairment Experimental Treatment 1 Intervention

Group II: Moderate Renal Impairment Experimental Treatment 1 Intervention

Group III: Mild Renal Impairment Experimental Treatment 1 Intervention

This arm will only be conducted if deemed necessary based on data in participants with moderate and severe renal impairment

Group IV: Healthy Volunteers Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Edgewise Therapeutics, Inc.

Lead Sponsor

Trials

13

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07034768

A Study to Evaluate EDG-7500 in People With Renal ... Study Overview. The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with ...

2. go.drugbank.com go.drugbank.com/conditions/DBCOND0038927

Impaired Renal Function (DBCOND0038927) A Study to Evaluate EDG-7500 in People With Renal Impairment. EDG-7500 ... The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9847092/

The prediction of in-hospital mortality in chronic kidney ... All patients diagnosed with CAD and CKD were included in this study. Patients who stayed in ICU for less than 6 h, less than 18 years old, ...

4. nature.com nature.com/articles/s41467-022-33623-z

Enhanced metanephric specification to functional proximal ... Enhanced metanephric specification to functional proximal tubule enables toxicity screening and infectious disease modelling in kidney organoids.

5. malacards.org malacards.org/card/arthrogryposis_renal_dysfunction_and_cholestasis_1

Arthrogryposis, Renal Dysfunction, and Cholestasis 1 Arthrogryposis, renal dysfunction, and cholestasis-1 (ARCS1) is a rare multisystem disorder characterized by congenital joint contractures, renal tubular ...

6. withpower.com withpower.com/trial/phase-1-renal-insufficiency-6-2025-73098

EDG-7500 for Kidney Failure It aims to understand how a single dose of EDG-7500 behaves in their bodies and its safety profile. I have kidney problems ranging from mild to severe.

7. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/EWTX/pressreleases/35739442/edgewise-therapeutics-edg-7500-study-a-potential-game-changer-for-renal-impairment-treatment/

Edgewise Therapeutics' EDG-7500 Study: A Potential ... ' The study aims to assess the pharmacokinetics and safety of EDG-7500, a drug administered in a single dose, in individuals with varying ...

8. hcplive.com hcplive.com/view/edg-7500-achieves-positive-phase-2-results-in-obstructive-hcm

EDG-7500 Achieves Positive Phase 2 Results in ... EDG-7500 was well-tolerated in healthy patients in Phase 1 while achieving gradient relief without LVEF reductions in the Phase 2 CIRRUS-HCM trial.

9. sec.gov sec.gov/Archives/edgar/data/1710072/000155837025002006/ewtx-20241231x10k.htm

Edgewise Therapeutics, Inc._December 31, 2024 Preclinical data of EDG-7500 support beneficial activity in animal models of both obstructive and non-obstructive HCM with diastolic benefit and minimal changes ...