A Double-Blind Randomized, Placebo-Controlled Phase 2 Clinical Trial to Evaluate Safety and Efficacy of US APR 2020 in Subjects with ChronicKidney Disease Stage IV

Abstract

Background: CKD is a common public health problem affecting over 200 million people worldwide. The United States accounted for about 30 million CKD patients with high morbidity, mortality and enormous health costs. Despite advancement in treatment options of risk factors for CKD like hypertension and diabetes, progression to end stage kidney disease and complications remain high. Observations of gut dysbiosis associated with progressive kidney disease, systemic inflammation and uremic toxin retention led to trial use of probiotics in restoring gut microbiome to ameliorate CKD. Studies have shown benefits in restoring gut microbiota with probiotics retarded progression, reduced uremic toxins, and improved quality of life in CKD. This clinical trial is to evaluate safety and efficacy of probiotic formulation US APR 2020 in patients with CKD stage 4 with an aim of retarding progression of CKD to End Stage Kidney Disease (ESRD). Methods: All eligible adult patients with CKD (eGFR 15-29 mls/min) with serum creatinine >2.5 mg/dl will be randomly assigned to either US APR 2020 (Group A) or Placebo (group B). The participants will be followed up monthly from baseline to 6 months of end of treatment with schedule of assessments at each visit. The primary end points will be based on <10% of adverse events and mean reduction of 40% decline in eGFR between the two groups at end of treatment. Discussion: This trial protocol outlined the design to evaluate Phase 2 safety and efficacy of FDA approved probiotic IND for treatment of patients in CKD stage 4 with primary objective of retarding renal disease progression. Data from this trial will inform planning for a Phase 3 clinical trial as part of unique and innovative drug development program for these categories of patients.