Clinical Trial To Evaluate Safety And Efficacy Of US-APR2020 In Subjects With Chronic Kidney Disease Stage IV (CKD)

Clinical Trial To Evaluate Safety And Efficacy Of US-APR2020 In Subjects With Chronic Kidney Disease Stage IV (CKD)

Brief Summary:
The aim of this Phase 2 study is to evaluate the safety and efficacy of the live biotherapeutic product, US-APR2020, in the management of patients with CKD Stage IV.

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 socio-economical 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.

The most important CKD risk factors in adults include diabetes and high blood pressure. Other risk factors include heart disease, obesity, a family history of CKD, past damage to the kidneys, and old age. Having CKD increases the chances of also having heart disease and stroke.

CKD is a condition characterized by a gradual loss of kidney function over time. Depending on the kidney function measured with glomerular filtration rate (GFR) CKD can be classified into several stages (I, II, III, IV and V). CKD Stage V, also known as End Stage Kidney Disease (ESKD), is a very advanced stage of kidney disease where the kidneys have lost nearly all ability to do their job effectively, and eventually dialysis or a kidney transplant is needed to live. Treatment may slow the decline in kidney function and failure. However, not everyone with CKD develops ESKD, and in some cases ESKD develops even with treatment.

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.

US-APR2020 is a live biotherapeutic (LBT) intended to restore the gut microbiome to improve the removal of uremic toxins in the bowel in CKD patients. The aim of this Phase 2 study is to evaluate the safety and efficacy of the US-APR2020 in the management of patients with CKD Stage IV.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter clinical trial to evaluate the safety and efficacy of US-APR2020 in patients with CKD Stage IV.

Following Screening and Enrollment, patients will be Randomized to either Group US-APR2020 or Placebo. In Group US-APR2020, the drug US-APR2020 will be administered orally at 2 capsules per day (one capsule in the morning and one capsule in the evening, after meals, for a total daily dose of 90 Billion CFUs) for six months. Subjects will be followed for 6 months. Patients in Placebo Group will be administered Placebo tablets in similar routine.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial To Evaluate Safety And Efficacy Of US-APR2020 In Subjects With Chronic Kidney Disease Stage IV
Estimated Study Start Date: June 2021
Estimated Primary Completion Date: December 2021
Estimated Study Completion Date: December 2021

Arm:
- Experimental: US-APR2020
- Placebo Comparator: Placebo

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