Study of US-APR2020 in subjects with CKD IV completing the US-APR2020-01 Study

Kibow Pharma is recruiting patients for the clinical trial of Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of US-APR2020 In Subjects With CKD IV Completing The US-APR2020-01 Study.

This is an Open-Label Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of US-APR2020 in Subjects With CKD IV Who Completed the US-APR2020-01 Study

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. 

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 US-APR2020 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, US-APR2020, in the management of patients with CKD Stage IV.

The researchers plan that April 21, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in March 2023.

Among primary outcome measures are the Evaluate the long-term safety of US-APR2020 in patients with Chronic Kidney Disease (CKD) Stage IV and Presence of adverse events in less than 10% of the study population, as a measure of safety Chronic Kidney Disease (CKD) Stage IV.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05407389.