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

Last updated: September 12, 2024
Sponsor: Kibow Pharma
Overall Status: Suspended

Phase

2

Condition

N/A

Treatment

Placebo

US-APR2020

Clinical Study ID

NCT04913272
US-APR2020-01
  • Ages 18-80
  • All Genders

Study Summary

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 patients with CKD Stage IV.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults between the ages of 18-80 years

  • CKD Stage IV (eGFR = 15-29 mL/min) with declining kidney function for a period > 6months

  • Serum Creatinine > 2.0 mg/dL

  • Adherence to low protein diet (LPD) of 0.6-0.8 g/kg/day based on subject responseand on advisory

Exclusion

Exclusion Criteria:

  • Those on probiotic supplements in the past 3 months

  • Pregnancy, breast feeding or females of child-bearing potential who are unwilling touse 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 timeof randomization or close to that visit.

  • Those with gastrointestinal disease (irritable bowel syndrome or anal fissures oranal fistulas or perianal abscesses or perianal infections or diverticular diseasesor colitis or colon polyps) at the time of screening and randomization, or within 6months 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 yearsshould 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 10years

  • Those on peritoneal dialysis

  • Those with acute kidney injury

  • Those with mental conditions or medically debilitating disease/disorder other thanCKD, which, in the judgment of the investigator, would interfere with or serve as acontraindication to adherence to the study protocol or affect the ability to giveinformed consent or affect overall prognosis of the patient.

Study Design

Total Participants: 630
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 24, 2021
Estimated Completion Date:
December 31, 2025

Study Description

Kidney diseases are a global public health problem that affects over 200 million people worldwide. It is estimated that about 30 million adults in the United States have Chronic Kidney Disease (CKD) and most are undiagnosed. In addition, CKD represents the ninth leading cause of death in the United States. Kidney diseases also represent great socio-economical cost worldwide. In the United States, treating Medicare beneficiaries with CKD costed over $79 billion, and treating people with End Stage Kidney Disease (ESKD) costed an additional $35 billion in 2016. To date, there is no cure for CKD.

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.

Connect with a study center

  • Jadedstone Clinical Research

    Silver Spring, Maryland 20904
    United States

    Site Not Available

  • Kidney Michigan

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • South Carolina Clinical Research

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Almeda Medical Clinic

    Houston, Texas 77058
    United States

    Site Not Available

  • Mendez Center for Clinical Research

    Woodbridge, Virginia 22192
    United States

    Site Not Available

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