A Phase 2 interventional study of US-APR2020 and Placebo in Chronic Kidney Disease stage4, sponsored by Kibow Pharma. Suspended at 5 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Kibow Pharma · Phase 2, Interventional, and Treatment
The aim of this Phase 2 study is to evaluate the safety and efficacy of the live biotherapeutic product, KT-301 (formerly US-APR2020), in the management of patients with CKD Stage IV.
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.
KT-301 (formerly 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 KT-301 in the management of patients with CKD Stage IV.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 630 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
Patients in this group will be administered KT-301 (formerly US-APR2020) orally at 2 capsules per day for six months. The frequency will be one capsule in the morning and one capsule in the evening, after meals, (for a total daily dose of 90 Billion CFUs).
Drug: US-APR2020
Patients in this group will be administered placebo orally at 2 capsules per day for six months. The frequency will be one capsule in the morning and one capsule in the evening, after meals.
Drug: Placebo
US-APR2020 capsules 45 billion CFUs of the LBT.
Placebo
Evaluate incidences of Treatment-Emergent Adverse Events following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of safety.
Presence of adverse events in less than 10% of the study population, as a measure of safety
Time frame: six months
Evaluate the change of eGFR as per NKF-USFDA guidelines following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of clinical efficacy.
Arresting the change of Estimated glomerular filtration rate (eGFR) as per National Kidney Foundation- US Food and Drug Administration (NKF-USFDA )guidelines in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo, as a measure of efficacy.
Time frame: six months
Evaluate changes in basic blood uremic metabolic markers
Change in any of the basic blood uremic metabolic markers in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo: * Blood Urea Nitrogen (BUN) * Uric acid * Serum creatinine * Urea/creatinine ratio * Micro albumin urea
Time frame: six months
Evaluate changes in complete blood count and hematology parameters
Change in any of the complete blood count (CBC) and hematology parameters in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo: * Red blood cells * White blood cells * Platelets * Hemoglobin (Hgb) * Hematocrit (Hct) Ferritin
Time frame: six months
Evaluate changes in C-Reactive Protein (CRP) levels
Change in C-Reactive Protein (CRP) levels in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo
Time frame: six months
Evaluate change in quality of life (QOL)- SF36 QOL questionnaire
Time frame: six months
This study is suspended, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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