Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV
NCT ID: NCT04913272
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
630 participants
INTERVENTIONAL
2021-06-24
2025-12-31
Brief Summary
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Detailed Description
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The most important CKD risk factors in adults include diabetes and high blood pressure. Other risk factors include heart disease, obesity, a family history of CKD, past damage to the kidneys, and old age. Having CKD increases the chances of also having heart disease and stroke.
CKD is a condition characterized by a gradual loss of kidney function over time. Depending on the kidney function measured with glomerular filtration rate (GFR) CKD can be classified into several stages (I, II, III, IV and V). CKD Stage V, also known as End Stage Kidney Disease (ESKD), is a very advanced stage of kidney disease where the kidneys have lost nearly all ability to do their job effectively, and eventually dialysis or a kidney transplant is needed to live. Treatment may slow the decline in kidney function and failure. However, not everyone with CKD develops ESKD, and in some cases ESKD develops even with treatment.
CKD is accompanied by altered pathogenic gut bacteria, inflammation, and accumulation of uremic toxins in the blood. These blood uremic toxins can diffuse passively into the bowel. Scientific research has shown that probiotic bacteria could metabolize various uremic toxins such as urea, uric acid, and creatinine. In addition, by supplementing the gut microbiome with probiotic bacteria, it is possible to metabolize the nitrogenous waste products and other toxins which diffuse into the gut, and thus lower levels of inflammation and blood uremic toxins.
KT-301 (formerly US-APR2020) is a live biotherapeutic (LBT) intended to restore the gut microbiome to improve the removal of uremic toxins in the bowel in CKD patients. The aim of this Phase 2 study is to evaluate the safety and efficacy of the KT-301 in the management of patients with CKD Stage IV.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Following Screening and Enrollment, patients will be Randomized to either Group KT-301 or Placebo. In Group KT-301, the drug KT-301 will be administered orally at 2 capsules per day (one capsule in the morning and one capsule in the evening, after meals, for a total daily dose of 90 Billion CFUs) for six months. Subjects will be followed for 6 months. Patients in Placebo Group will be administered Placebo tablets in similar routine.
TREATMENT
QUADRUPLE
Study Groups
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KT-301 (formerly US-APR2020)
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).
US-APR2020
US-APR2020 capsules 45 billion CFUs of the LBT.
Placebo
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.
Placebo
Placebo
Interventions
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US-APR2020
US-APR2020 capsules 45 billion CFUs of the LBT.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* CKD Stage IV (eGFR = 15-29 mL/min) with declining kidney function for a period \> 6 months
* Serum Creatinine \> 2.0 mg/dL
* Adherence to low protein diet (LPD) of 0.6-0.8 g/kg/day based on subject response and on advisory
Exclusion Criteria
* Pregnancy, breast feeding or females of child-bearing potential who are unwilling to use a reliable form of contraception.
* Immunosuppressant medications therapy specific to immune mediated renal diseases
* HIV/AIDs
* Underweight (BMI ≤ 18.5)
* Subject with an infection that requires oral antibiotic administration at the time of randomization or close to that visit.
* Those with gastrointestinal disease (irritable bowel syndrome or anal fissures or anal fistulas or perianal abscesses or perianal infections or diverticular diseases or colitis or colon polyps) at the time of screening and randomization, or within 6 months prior to the randomization visit (Visit 2)
* Those with internal prosthesis including orthopedics, neurosurgery, heart valves, vascular stents ˂ 2 years post -surgery procedure. Those with Prosthesis \> 2 years should not be excluded.
* Those with biological/tissue grafts or prosthesis or implant
* Those on anticoagulant medicines, including Vit K antagonists (e.g., warfarin, coumadin) or the new class of oral anti-coagulants approved by FDA in the last 10 years
* Those on peritoneal dialysis
* Those with acute kidney injury
* Those with mental conditions or medically debilitating disease/disorder other than CKD, which, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol or affect the ability to give informed consent or affect overall prognosis of the patient.
18 Years
80 Years
ALL
No
Sponsors
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Kibow Pharma
INDUSTRY
Responsible Party
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Locations
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Jadedstone Clinical Research
Silver Spring, Maryland, United States
Kidney Michigan
Saginaw, Michigan, United States
South Carolina Clinical Research
Orangeburg, South Carolina, United States
Almeda Medical Clinic
Houston, Texas, United States
Mendez Center for Clinical Research
Woodbridge, Virginia, United States
Countries
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Other Identifiers
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US-APR2020-01
Identifier Type: -
Identifier Source: org_study_id
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