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

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ClinicalTrials.gov Identifier: NCT04913272
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : June 3, 2022
Sponsor:
Information provided by (Responsible Party):
Kibow Pharma

Brief Summary:
The aim of this Phase 2 study is to evaluate the safety and efficacy of the live biotherapeutic product, US-APR2020, in the management of patients with CKD Stage IV.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease stage4 Drug: US-APR2020 Drug: Placebo Phase 2

Detailed 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.

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 US-APR2020 in the management of patients with CKD Stage IV.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter clinical trial to evaluate the safety and efficacy of US-APR2020 in patients with CKD Stage IV.

Following Screening and Enrollment, patients will be Randomized to either Group US-APR2020 or Placebo. In Group US-APR2020, the drug US-APR2020 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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial To Evaluate Safety And Efficacy Of US-APR2020 In Subjects With Chronic Kidney Disease Stage IV
Actual Study Start Date : June 24, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: US-APR2020
Patients in this group will be administered 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).
Drug: US-APR2020
US-APR2020 capsules 45 billion CFUs of the LBT.

Placebo Comparator: 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.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Evaluate incidences of Treatment-Emergent Adverse Events following US-APR2020 administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of safety. [ Time Frame: six months ]
    Presence of adverse events in less than 10% of the study population, as a measure of safety

  2. Evaluate the change of eGFR as per NKF-USFDA guidelines following US-APR2020 administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of clinical efficacy. [ Time Frame: six months ]
    Arresting the change of Estimated glomerular filtration rate (eGFR) as per National Kidney Foundation- US Food and Drug Administration (NKF-USFDA )guidelines in the group treated with US-APR2020 as compared to the placebo, as a measure of efficacy.


Secondary Outcome Measures :
  1. Evaluate changes in basic blood uremic metabolic markers [ Time Frame: six months ]

    Change in any of the basic blood uremic metabolic markers in the group treated with US-APR2020 as compared to the placebo:

    • Blood Urea Nitrogen (BUN)
    • Uric acid
    • Serum creatinine
    • Urea/creatinine ratio
    • Micro albumin urea

  2. Evaluate changes in complete blood count and hematology parameters [ Time Frame: six months ]

    Change in any of the complete blood count (CBC) and hematology parameters in the group treated with US-APR2020 as compared to the placebo:

    • Red blood cells
    • White blood cells
    • Platelets
    • Hemoglobin (Hgb)
    • Hematocrit (Hct) Ferritin

  3. Evaluate changes in C-Reactive Protein (CRP) levels [ Time Frame: six months ]
    Change in C-Reactive Protein (CRP) levels in the group treated with US-APR2020 as compared to the placebo

  4. Evaluate change in quality of life (QOL)- SF36 QOL questionnaire [ Time Frame: six months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 > 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:

  • Those on probiotic supplements in the past 3 months
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04913272


Contacts
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Contact: Mukesh Kumar, PhD 2407504893 mkumar@fdamap.com

Locations
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United States, Maryland
Jadedstone Clinical Research Recruiting
Silver Spring, Maryland, United States, 20904
Contact: Mukesh Kumar    240-750-4893    mkumar@fdamap.com   
United States, Michigan
Kidney Michigan Recruiting
Saginaw, Michigan, United States, 48604
Contact: Mukesh Kumar    240-750-4893    mkumar@fdamap.com   
United States, South Carolina
South Carolina Clinical Research Recruiting
Orangeburg, South Carolina, United States, 29118
Contact: Mukesh Kumar    240-750-4893    mkumar@fdamap.com   
United States, Texas
Almeda Medical Clinic Recruiting
Houston, Texas, United States, 77058
Contact: Mukesh Kumar    240-750-4893    mkumar@fdamap.com   
United States, Virginia
Mendez Center for Clinical Research Recruiting
Woodbridge, Virginia, United States, 22192
Contact: Mukesh Kumar    240-750-4893    mkumar@fdamap.com   
Sponsors and Collaborators
Kibow Pharma
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Responsible Party: Kibow Pharma
ClinicalTrials.gov Identifier: NCT04913272    
Other Study ID Numbers: US-APR2020-01
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency