CLINICAL TRIAL PHASE 2B
for
Patients with Chronic Kidney Disease Stage 4

What is this Chronic Kidney Disease trial about?

The purpose of this study to evaluate the safety and efficacy of an investigational medication in individuals with chronic kidney disease stage 4. This purpose of this FDA-approved Investigational drug is to determine safety and its ability to reduce or slow progression of patients who have been diagnosed with Chronic Kidney Disease (CKD) stage 4 and how it impacts on their quality of life.

About CKD stage 4 Clinical trial

The objective of this study is to evaluate the safety and efficacy of an investigational medication in patients with chronic kidney disease stage 4. CKD is a condition characterized by gradual loss of kidney function over time. Chronic kidney disease is classified based on kidney function measured with glomerular filtration rate (GFR) into several stages of 1, II, III, IV, and V. The CKD stage V is advanced stage of kidney disease where the kidneys have lost nearly all ability to function effectively and ultimately dialysis or kidney transplant is needed to live. Treatment may slow the decline in kidney function and failure.

Who Can Participate in the Chronic Kidney Disease Trial?

You are eligible to participate if the following conditions are met:
  • Above the age of 18 years
  • Diagnosed as CKD stage 4 (estimated GFR 15- 29 mls/min)
  • Serum Creatinine level greater than 2.5 mg/Mls
  • Ability to follow a low protein diet

You will not be eligible if the following conditions apply
  • Probiotics use in the past 3 months
  • Pregnant or breast feeding
  • On immunosuppressive medications for immune mediated kidney disorder
  • Severe infectious conditions or other conditions as assessed by the investigator that may make it difficult to follow the study protocol.
​
Research Site: Lifespan Medical Services, Address: 1125 Forrest Avenue Suite 203, Dover DE 19904. Click Here for details on CKD Research Site.

Contact: 410 501 5777

Study Drug and Purpose: US-APR2020 is a probiotic formulation intended to restore the gut bacteria balance to improve the removal of uremic toxins in the bowel in CKD patients. This Phase 2b study is to evaluate the safety and efficacy of the probiotics in the management of patients with CKD Stage IV.

Study Regimen: You'll be given either study drug or placebo, oral, twice a day for 6 months.

Study Visit: One screening visit and 6 follow-up office visits (Day 1, 8, 30, 60, 90. And 180) that include physical exams and blood tests. Study Cost: All study drugs and tests are provided by the sponsor.
​20212330
#32018164.0
 
IRB Approved As
Modified at the
Protocol Level
Sep 12, 2021
Phone: 410-501-5777
​Inquiry Form: