Trial Name: Kibow Pharmaceuticals (Phase 2B study of US- APR 2020)
Description: 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 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. It is well known not all patients with CKD develop end stage kidney disease (ESKD) and in some cases ESKD still develop with treatment. Research findings showed that patients with CKD have significant changes in their intestinal bacterial, inflammation and accumulation of uremic toxins. It is proven in many studies that certain specific types of these intestinal bacteria (called gut microbiome) could metabolize high uremic toxins like urea, creatine, uric acid. The idea of this study is that supplementing the gut microbiome with probiotic bacteria could possibly metabolize the nitrogenous waste products and other toxins which diffuse into the gut and therefore lower the levels of these inflammation and blood uremic toxins in CKD patients. The investigational drug is a probiotic formulation intended to restore the gut bacteria balance to improve removal of uremic toxins in the bowel of CKD patients. Probiotics are live bacteria (the type in yoghurt and some variety of cheese, etc). Since these bacteria are found in food, they are regarded generally as safe and previous experiments have indicated this product may be useful in the treatment of CKD.
Who Can Participate in the 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.
The trial will recruit 630 patients at 20 sites to participate in the study. This is a controlled study where half of the study participants will get the experimental drug while the other half will get a placebo. Neither you nor your doctors will know if you are getting the experimental treatment or the placebo. The study duration will be 6 months consisting of monthly visits. At each visit your doctor will carry out series of tests and find out from you about any reactions and state of health. At the end of study, all information from participants will be analyzed to determine if the drug is safe and effective in management of CKD patients.