Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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An Open-Label Rollover Extension Phase 2 Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study

Conditions
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Chronic Kidney Disease stage4

Intervention / Treatment
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* Drug: KT-301 (formerly US-APR2020)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an extension open-label multicenter study to evaluate the long-term safety and efficacy of KT-301 (formerly US-APR2020) in patients with CKD Stage IV. KT-301 will be administered orally at 2 capsules per day (a total dose of 90 Billion CFUs per day of the Live BioTherapeutic).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KT-301 (formerly US-APR2020)<br> | Drug: KT-301 (formerly US-APR2020)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate changes in basic blood uremic metabolic markers |  | 6 months | 
| Evaluate changes in complete blood count and hematology parameters |  | 6 months | 
| Reduction in C-Reactive Protein (CRP) levels following date of roll-over transition until study competition |  | 6 months | 
| Percent change in rating scale (Modified SF36 QOL questionnaire) from roll-over transition until study competition (at 24-weeks) |  | 6 months |