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Live Biotherapeutic Product
KT-301 for Chronic Kidney Disease Stage IV (CKD Trial)
Phase 2
Waitlist Available
Research Sponsored by Kibow Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Summary
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.
Eligible Conditions
- End Stage Renal Disease (ESRD)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate incidences of Treatment-Emergent Adverse Events following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of safety.
Evaluate the change of eGFR as per NKF-USFDA guidelines following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of clinical efficacy.
Secondary study objectives
Evaluate changes in C-Reactive Protein (CRP) levels
Evaluate changes in basic blood uremic metabolic markers
Evaluate changes in complete blood count and hematology parameters
Trial Design
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.
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Who is running the clinical trial?
Kibow PharmaLead Sponsor
5 Previous Clinical Trials
871 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken probiotic supplements in the last 3 months.You are currently taking medications that weaken your immune system for kidney diseases.You have HIV/AIDS.You are very thin based on your weight and height.You are taking certain blood-thinning medications, like warfarin or newer oral anti-coagulants approved by the FDA in the last 10 years.You are currently undergoing peritoneal dialysis.You have a recent kidney problem.You are between 18 and 80 years old.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.You have an infection that needs to be treated with oral antibiotics when you start the study or around that time.You had surgery to implant a prosthesis (like a joint replacement or heart valve) less than 2 years ago. If it's been more than 2 years, this criterion doesn't apply to you.You have had a biological tissue graft, prosthesis, or implant.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: KT-301 (formerly US-APR2020)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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