630 Participants Needed

KT-301 for Chronic Kidney Disease Stage IV

(CKD Trial)

Recruiting at 22 trial locations
MK
Overseen ByMukesh Kumar, PhD
Prior Safety DataThis treatment has passed at least one previous human trial

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.
See 10 more

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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: KT-301 (formerly US-APR2020)Experimental Treatment1 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: PlaceboPlacebo Group1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kibow Pharma

Lead Sponsor

Trials
6
Recruited
1,500+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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