KT-301 for Chronic Kidney Disease Stage IV

(CKD Trial)

Not currently recruiting at 22 trial locations

Overseen By Mukesh Kumar, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kibow Pharma

Must not be taking: Probiotics, Immunosuppressants, Anticoagulants

Disqualifiers: HIV/AIDS, Gastrointestinal disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment, KT-301 (formerly US-APR2020), for individuals with stage IV chronic kidney disease (CKD). Participants will receive either KT-301 or a placebo and take two capsules daily for six months. The study seeks individuals whose kidney function has declined for over six months and who follow a low-protein diet. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on probiotic supplements, immunosuppressant medications for immune-related kidney diseases, or anticoagulant medicines. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that KT-301 is likely to be safe for humans?

Research has shown that KT-301, a treatment using live bacteria, has been tested for safety in people with advanced kidney disease. In earlier studies, less than 10% of patients experienced unwanted side effects, indicating that KT-301 is generally well-tolerated. However, as with any treatment, individual experiences may vary. ^{1 2 3 4 5}

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

Unlike the standard treatments for chronic kidney disease, which often include medications like ACE inhibitors or ARBs, KT-301 introduces a novel approach by utilizing a probiotic formulation. This treatment is unique because it delivers a specific dose of 90 billion CFUs of beneficial bacteria per day, targeting gut health to potentially influence kidney function. Researchers are excited about this new method because it offers a different mechanism of action, focusing on the gut-kidney axis, which might not only improve kidney health but also provide additional health benefits.

What evidence suggests that KT-301 might be an effective treatment for chronic kidney disease?

Research has shown that KT-301, a treatment made from live bacteria, might aid people with Stage IV Chronic Kidney Disease by improving gut health and reducing harmful substances in the blood. Early studies with patients demonstrated positive changes in the gut, potentially slowing kidney damage. The treatment balances the body's natural bacteria and reduces inflammation. Although more research is needed, these early results offer promise for those with advanced kidney disease. Participants in this trial will receive either KT-301 or a placebo to further evaluate its effectiveness. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

Your kidneys are not working well, and this has been going on for more than 6 months.

Your blood creatinine level is higher than 2.0 mg/dL.

You need to follow a low protein diet of 0.6-0.8 grams per kilogram of body weight each day, as advised.

Exclusion Criteria

Pregnancy, breast feeding or females of child-bearing potential who are unwilling to use a reliable form of contraception

You have taken probiotic supplements in the last 3 months.

You are currently taking medications that weaken your immune system for kidney diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KT-301 or placebo orally at 2 capsules per day for six months

24 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KT-301 (formerly US-APR2020)

How Is the Trial Designed?

Group I: KT-301 (formerly US-APR2020) Experimental Treatment 1 Intervention

Patients in this group will be administered KT-301 (formerly US-APR2020) orally at 2 capsules per day for six months. The frequency will be one capsule in the morning and one capsule in the evening, after meals, (for a total daily dose of 90 Billion CFUs).

Group II: Placebo Placebo Group 1 Intervention

Patients in this group will be administered placebo orally at 2 capsules per day for six months. The frequency will be one capsule in the morning and one capsule in the evening, after meals.

Who Is Running the Clinical Trial?

Kibow Pharma

Lead Sponsor

Trials

6

Recruited

1,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04913272

Clinical Trial To Evaluate Safety And Efficacy Of KT-301 ... This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter clinical trial to evaluate the safety and efficacy of KT-301 (formerly US-APR2020) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05407389

Study Details | NCT05407389 | Rollover Extension ... The purpose of this open-label study is to evaluate the long-term safety and efficacy of the live biotherapeutic product, KT-301, in the management of patients ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0073091

Stage 4 Chronic Kidney Disease (DBCOND0073091) NCT04913272. Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV. APR-2020.

4. ctv.veeva.com ctv.veeva.com/study/clinical-trial-to-evaluate-safety-and-efficacy-of-kt-301-formerly-us-apr2020-in-subjects-with-chro

Clinical Trial To Evaluate Safety And Efficacy Of KT-301 ... The aim of this Phase 2 study is to evaluate the safety and efficacy of the live biotherapeutic product, KT-301 (formerly US-APR2020), in the management of ...

5. withpower.com withpower.com/trial/phase-3-kidney-diseases-5-2021-19dd8

KT-301 for Chronic Kidney Disease Stage IV (CKD Trial) This trial is testing KT-301, a live bacteria treatment, on patients with CKD Stage IV. The goal is to see if it can improve gut health and reduce harmful blood ...

6. app.trialscreen.org app.trialscreen.org/trials/phase-2-3-chronic-kidney-disease-stage4-rollover-extension-clinical-to-trial-nct05407389

Rollover Extension Clinical Trial To Evaluate The Long ... This open-label, multicenter, rollover extension study evaluates the long-term safety and efficacy of the live biotherapeutic product, KT-301, ...