ESK-001 for Kidney Failure

Recruiting at 3 trial locations

Overseen By Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alumis Inc

Disqualifiers: Metabolic, Hepatic, Psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ESK-001 to understand its behavior in the body. The focus includes both healthy individuals and those with varying degrees of kidney problems. Researchers aim to determine how the treatment is processed in people with mild, moderate, and severe kidney issues. Ideal candidates have stable kidney function, do not require dialysis, and have not undergone certain stomach surgeries. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

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

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

Is there any evidence suggesting that ESK-001 is likely to be safe for humans?

Research has shown that ESK-001 is being tested in other studies to assess its safety. In one ongoing study, a few participants experienced side effects, such as heart problems in one person and side pain in another. These are just a couple of reported cases. It is important to remember that this drug is still under investigation, and more information is needed to fully understand its safety. Since the trial under consideration is in an early stage, the main goal is to observe how the drug works in the body. At this point, there is usually limited safety information available. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for kidney failure focus on managing symptoms or slowing disease progression, often involving dialysis or transplants. But ESK-001 works differently. Researchers are excited about ESK-001 because it has a novel mechanism of action that targets the underlying causes of kidney impairment, potentially offering a more direct approach to treatment. Unlike standard care, which is often invasive and time-consuming, ESK-001 could provide a simpler, single-dose solution, making it a promising option for both patients and healthcare providers.

What evidence suggests that ESK-001 might be an effective treatment for kidney failure?

Research has shown that ESK-001 might be a promising treatment for kidney problems. Early results suggest that ESK-001 could be effective for individuals with varying levels of kidney function, from mild to severe issues. In this trial, participants with different degrees of renal impairment, along with healthy volunteers, will receive a single dose of ESK-001 to study its effects. Researchers aim to understand how the drug works in the body when the kidneys aren't functioning perfectly. Although specific data on its effectiveness for kidney failure is not yet available, the research into its impact on kidney function appears hopeful. Further studies are needed to confirm these early results. ^{1 4 5 6 7}

Who Is on the Research Team?

Jorn Drappa, Medical Director

Principal Investigator

Alumis Inc

Are You a Good Fit for This Trial?

This trial is for adults with varying levels of kidney function, from normal to severely impaired. It's not clear what specific conditions exclude someone from participating, but typically those with other serious health issues or who are taking conflicting medications might be ineligible.

Inclusion Criteria

Body mass index between 18.0 and 40.0 kg/m2

Exclusion Criteria

I haven't had major stomach or intestinal surgery affecting drug absorption, except for appendectomy, gallbladder removal, or hernia repair.

I do not have any significant health issues apart from my current condition.

I have kidney issues but no uncontrolled health problems in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of ESK-001 to assess pharmacokinetics

1 day

Follow-up

Participants are monitored for safety and pharmacokinetic outcomes after receiving the dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ESK-001

Trial Overview The study is testing ESK-001 in different groups based on their kidney health: healthy volunteers and those with mild, moderate, or severe impairment. The goal is to see how the drug moves through the body (pharmacokinetics) at a single dose across these groups.

How Is the Trial Designed?

Group I: Severe Renal Impairment Experimental Treatment 1 Intervention

8 participants with severe Renal impairment will receive a single dose of ESK-001

Group II: Moderate Renal Impairment Experimental Treatment 1 Intervention

8 participants with moderate renal impairment will receive a single dose of ESK-001

Group III: Mild Renal Impairment Experimental Treatment 1 Intervention

8 participants with mild renal impairment will receive a single dose of ESK-001

Group IV: Healthy Volunteer Experimental Treatment 1 Intervention

Up to 24 healthy volunteer participants will receive a single dose of ESK-001

Who Is Running the Clinical Trial?

Alumis Inc

Lead Sponsor

Trials

9

Recruited

4,200+

Citations

1. tipranks.com tipranks.com/news/company-announcements/alumis-inc-s-esk-001-study-a-potential-game-changer-for-renal-impairment-treatment

Alumis Inc.'s ESK-001 Study: A Potential Game-Changer ... ' The study aims to understand how renal impairment affects the pharmacokinetics of ESK-001, a drug administered to participants with varying ...

2. ctv.veeva.com ctv.veeva.com/study/a-phase-i-study-to-investigate-the-effects-of-renal-impairment-on-the-pharmacokinetics-safety-and

A Phase I Study to Investigate the Effects of Renal Impairment ... This study is being conducted to investigate the PK, safety, and tolerability of opemalirsen in participants with renal impairment, compared to ...

3. investors.alumis.com investors.alumis.com/node/7026/pdf

Alumis Presents Data Highlighting ESK-001's Potential as a ... ESK-001 could potentially become a high efficacy oral treatment option for patients with SLE. Our team continues to advance the Phase 2b ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-investigational-esk-participants-normal-renal-function-mild-moderate-trial-nct06962774

An Investigational Study of ESK-001 in Participants ... An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-reducing-protein-in-urine-for-patients-with-chronic-kidney-disease-using-finerenone-and-semaglutide/

Study on Reducing Protein in Urine for Patients with ... This study investigates the efficacy of finerenone and semaglutide in reducing proteinuria in patients with Chronic Kidney Disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6933464/

Steroid-Associated Side Effects in Patients With Primary ... The goal of this study was to assess the occurrence of steroid-associated adverse events (SAAE) in patients with primary proteinuric kidney disease.

7. alumis.com alumis.com/file.cfm/18/docs/alumis_pub_2_for_website_aad_pres_vf.pdf

Efficacy and Safety of ESK-001, a Highly Selective Oral ... Safety data displayed based on 8 December 2023 data cut of ongoing OLE study. ... chronic cardiac failure in one subject, and flank pain in one subject ...