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Chronic Kidney Disease stage4Phase 2CKDNCT04913272

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

A Phase 2 study testing US-APR2020 in people with Chronic Kidney Disease stage4, run by Kibow Pharma at 5 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Kidney Disease stage4
What is being tested?
US-APR2020
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
630 participants
Where
5 sitesUnited States
Study dates
24 Jun 2021to Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Almeda Medical Clinic

    Houston, Texas, 77058

  • South Carolina Clinical Research

    Orangeburg, South Carolina, 29118

  • Kidney Michigan

    Saginaw, Michigan, 48604

  • Jadedstone Clinical Research

    Silver Spring, Maryland, 20904

  • Mendez Center for Clinical Research

    Woodbridge, Virginia, 22192

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV

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.

Read the 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.

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.

Being tested
US-APR2020, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • US-APR2020Drug

    US-APR2020 capsules 45 billion CFUs of the LBT.

  • PlaceboDrug

    Placebo

Study groups in NCT04913272
Study groupRoleWhat they receive
KT-301 (formerly US-APR2020)ExperimentalPatients 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).
Receives: Drug: US-APR2020
PlaceboPlacebo comparatorPatients 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Presence of adverse events in less than 10% of the study population, as a measure of safety

    Measured: six months

  2. 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.

    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 KT-301 (formerly US-APR2020) as compared to the placebo, as a measure of efficacy.

    Measured: six months

Secondary outcomes (4)

  1. Evaluate changes in basic blood uremic metabolic markers

    Change in any of the basic blood uremic metabolic markers in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo:

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

    Measured: six months

  2. Evaluate changes in complete blood count and hematology parameters

    Change in any of the complete blood count (CBC) and hematology parameters in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo:

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

    Measured: six months

  3. Evaluate changes in C-Reactive Protein (CRP) levels

    Change in C-Reactive Protein (CRP) levels in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo

    Measured: six months

  4. Evaluate change in quality of life (QOL)- SF36 QOL questionnaire

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start24 Jun 2021
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: Logistics, company reorganization

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter clinical trial to evaluate the safety and efficacy of KT-301 (formerly US-APR2020) in patients with CKD Stage IV. 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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913272
Sponsor's protocol ID
US-APR2020-01
Acronym
CKD
Status last verified
Sep 2024
First submitted
21 May 2021
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing US-APR2020 in people with Chronic Kidney Disease stage4, run by Kibow Pharma at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04913272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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