Clinical trial NCT05407389: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Disease stage4
Lead sponsor: Kibow Pharma
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: TREATMENT

Brief 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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the long-term safety of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV
timeFrame: 6 months
measure: Evaluate the clinical efficacy of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate changes in basic blood uremic metabolic markers
timeFrame: 6 months
measure: Evaluate changes in complete blood count and hematology parameters
timeFrame: 6 months
measure: Reduction in C-Reactive Protein (CRP) levels following date of roll-over transition until study competition
timeFrame: 6 months
measure: Percent change in rating scale (Modified SF36 QOL questionnaire) from roll-over transition until study competition (at 24-weeks)
timeFrame: 6 months
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Jadedstone Clinical Research
state: Maryland
city: Saginaw
country: United States
facility: Kidney Michigan
state: Michigan
city: Orangeburg
country: United States
facility: South Carolina Clinical Research
state: South Carolina
city: Houston
country: United States
facility: Almeda Medical Clinic
state: Texas
city: Woodbridge
country: United States
facility: Mendez Center for Clinical Research
state: Virginia
Study officials:
References: