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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05407389
Other study ID # US-APR2020-02
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 21, 2022
Est. completion date March 2024

Study information

Verified date October 2023
Source Kibow Pharma
Contact Mukesh Kumar
Phone 2407504893
Email mkumar@fdamap.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an Open-Label Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of KT-301 (formerly US-APR2020) in Subjects With CKD IV Who Completed the US-APR2020-01 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 socioeconomical 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. 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 probiotic formulation of bacteria intended to restore the gut bacteria balance to improve the removal of uremic toxins in the bowel in CKD patients. This is an open label, multicenter, rollover extension study to provide KT-301 to subjects who were previously enrolled into and completed the placebo-controlled study, US-APR2020-01. Subjects will roll over to the long-term extension study at the last visit of the US-APR-2020-01 study. All subjects who completed the US-APR2020-01 study will be eligible to enroll in this study. The purpose of this open-label study is to evaluate the long-term safety and efficacy of the live biotherapeutic product, KT-301, in the management of patients with CKD Stage IV.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Completion of US-APR2020-01 study - Adults between the ages of 18-80 years Exclusion Criteria: - Did not participate in the placebo-controlled study US-APR2020-01 - Withdrew from US-APR2020-01 study prior to completing the 6 months treatment for any reason - Unwilling or unable to visit the site for the follow-up visits

Study Design


Intervention

Drug:
KT-301 (formerly US-APR2020)
KT-301 (formerly US-APR2020) will be administered orally at 2 capsules per day (a total dose of 90 Billion CFUs per day of the Live BioTherapeutic).

Locations

Country Name City State
United States Almeda Medical Clinic Houston Texas
United States South Carolina Clinical Research Orangeburg South Carolina
United States Kidney Michigan Saginaw Michigan
United States Jadedstone Clinical Research Silver Spring Maryland
United States Mendez Center for Clinical Research Woodbridge Virginia

Sponsors (1)

Lead Sponsor Collaborator
Kibow Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the long-term safety of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV Presence of adverse events in less than 10% of the study population, as a measure of safety Chronic Kidney Disease (CKD) Stage IV 6 months
Primary Evaluate the clinical efficacy of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV Arresting the decline of eGFR as per NKF-USFDA guidelines following date of roll- over transition until study competition, compared to baseline (End of study for US- APR2020-01) as a measure of clinical efficacy 6 months
Secondary Evaluate changes in basic blood uremic metabolic markers 6 months
Secondary Evaluate changes in complete blood count and hematology parameters 6 months
Secondary Reduction in C-Reactive Protein (CRP) levels following date of roll-over transition until study competition 6 months
Secondary Percent change in rating scale (Modified SF36 QOL questionnaire) from roll-over transition until study competition (at 24-weeks) 6 months
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