KT-301 for Chronic Kidney Disease Stage IV

(CKD Trial)

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

630 Participants Needed

Trial Summary

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.

What is the purpose of this 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 toxins and inflammation.

Eligibility Criteria

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

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

Treatment Details

Interventions

• KT-301 (formerly US-APR2020)

Participant Groups

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+