SAP-001 for Kidney Failure

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Shanton Pharma Pte. Ltd.

Must not be taking: St. John's wort, Enzyme-modifying drugs

Disqualifiers: Pregnancy, HIV, Hepatitis B, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, SAP-001 (experimental treatment), for individuals with varying levels of kidney function, including those with mild to severe kidney issues, as well as healthy individuals for comparison. The researchers aim to understand how the body processes the drug in people with different kidney conditions. This trial serves as a first step to ensure the treatment's safety and to understand its effects. It may suit adults with stable kidney conditions or healthy individuals without major health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

If you have renal impairment and are on treatment for it or another chronic condition, you must be on a stable treatment plan for at least 14 days before and during the study. Some small changes in medication doses might be allowed, but this will be decided on a case-by-case basis. For those with normal renal function, you should not use prescription drugs, over-the-counter drugs, or certain natural health products before the study.

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

Research has shown that SAP-001 was safe in earlier studies. These studies, involving patients with uncontrolled gout, did not identify any major safety issues but did not provide detailed information about specific side effects. SAP-001 is being tested to lower uric acid levels, which might also benefit kidney function.

Since this trial is in its early stages, it aims to assess how well participants tolerate SAP-001. The researchers are still gathering information about its safety, especially because the trial includes people with varying kidney function levels. As with any new treatment at this stage, monitoring for side effects is important. ^{1 2 3 4 5}

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

SAP-001 is unique because it offers a potential new approach to treating kidney failure by specifically targeting different levels of renal impairment. Unlike current treatments, which typically include dialysis or kidney transplants, SAP-001 is being tested across groups with mild, moderate, and severe renal impairment, as well as a healthy control group. Researchers are excited about SAP-001 because it could tailor treatment to the severity of kidney issues, potentially leading to more personalized and effective therapy options.

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

Research has shown that SAP-001 effectively treats issues related to uric acid levels. Nearly all patients with uncontrolled gout who took SAP-001 at doses of 30mg and 60mg achieved their desired uric acid levels within 12 weeks. This indicates that SAP-001 can significantly lower uric acid, which often poses a problem for the kidneys. Although limited information exists on SAP-001 specifically for kidney failure, its ability to control uric acid levels might aid kidney function, as high uric acid can damage the kidneys. This trial will evaluate SAP-001 in participants with varying degrees of renal impairment, and these promising results suggest SAP-001 might benefit kidney health. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with different levels of kidney function, including those with kidney failure, gout, or high uric acid levels. Up to 32 participants will be divided into 4 groups based on their kidney health.

Inclusion Criteria

1. Provision of signed and dated informed consent form (ICF)

2. Subject is, as stated and in the opinion of the Investigator, willing and able to comply with the study drug regimen and all other protocol and study procedures and requirements, and is available for the duration of the study

3. Adult male or female

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of SAP-001 and are monitored for pharmacokinetics and safety

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• SAP-001

Trial Overview The study is testing SAP-001, a new treatment, in a single-dose study across multiple centers. It's an open-label and non-randomized trial, meaning everyone knows what treatment they're getting and they're not assigned by chance.

How Is the Trial Designed?

Group I: Severe renal impairment Experimental Treatment 1 Intervention

Subjects with severe renal impairment(Optional)

Group II: Moderate renal impairment Experimental Treatment 1 Intervention

Subjects with moderate renal impairment

Group III: Mild renal impairment Experimental Treatment 1 Intervention

Subjects with mild renal impairment

Group IV: Healthy match Experimental Treatment 1 Intervention

Matched healthy subjects with normal renal function

Who Is Running the Clinical Trial?

Shanton Pharma Pte. Ltd.

Lead Sponsor

Trials

2

Recruited

120+

Citations

1. renalandurologynews.com renalandurologynews.com/news/novel-oral-therapy-for-uncontrolled-gout-gets-fast-track-designation/

Novel Oral Therapy for Uncontrolled Gout Gets Fast Track ... Findings showed that at 12 weeks, nearly 100% of patients treated with SAP-001 at the 30mg and 60mg doses achieved the target serum uric acid ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03206658

Spironolactone on Acute Kidney Injury in Critically Ill Patients This study was designed to evaluate the effect of spironolactone administration in the incidence and severity of AKI in patients critically ill.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7819867/

Efficacy and safety of urate-lowering therapy in people with ... There were 36 reports with an analysis of efficacy and/or safety based upon renal function: allopurinol (n = 12), febuxostat (n = 10), probenecid (n = 3), ...

4. ashpublications.org ashpublications.org/bloodadvances/article/9/13/3129/536049/Early-daratumumab-therapy-improves-renal-outcomes

Early daratumumab therapy improves renal outcomes in ... Their study showed a 90% reduction of sFLC in 80% at 1 month and renal response rate of 76% at 3 months, similar to our cohort. Our study had ...

5. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2024/05/29/17/23/flow

Evaluate Renal Function With Semaglutide Once Weekly The FLOW trial showed that among patients with CKD and DM2, once weekly subcutaneous semaglutide was superior to placebo in improving renal and CV outcomes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06729853

NCT06729853 | PK and Safety Evaluation Study of SAP- ... Renal impairment should be stable for at least 1 month prior to Screening (change in eGFR should not be more than 25%).

7. hcplive.com hcplive.com/view/sap-001-demonstrates-best-in-class-data-gout-hyperuricemia-refractory-soc-xoi-therapy

SAP-001 Demonstrates “Best in Class” Data for Gout With ... By 3 months, nearly all patients confirmed exposed to 30 or 60 mg SAP-001 reached serum uric acid levels below 6mg/dL.

8. empr.com empr.com/news/novel-oral-therapy-for-uncontrolled-gout-gets-fast-track-designation/

Novel Oral Therapy for Uncontrolled Gout Gets Fast Track ... SAP-001 is an investigational oral agent designed to reduce serum uric acid levels by targeting a distinct renal urate reabsorption transporter.

9. the-rheumatologist.org the-rheumatologist.org/article/sap-001-promising-for-refractory-gout/

SAP-001 Promising for Refractory Gout The study also demonstrated a positive safety profile (data not reported). The company plans to run phase 3 trials to further assess SAP ...