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

Chronic Kidney Disease stage4 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407389
• Other study ID #: US-APR2020-02
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease stage4
• Kidney Diseases
• Renal Insufficiency, Chronic

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