A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV

Description

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

Trial Eligibility

Inclusion Criteria: * Adults between the ages of 18-80 years * CKD Stage IV (eGFR = 15-29 mL/min) with declining kidney function for a period \> 6 months * Serum Creatinine \> 2.0 mg/dL * Adherence to low protein diet (LPD) of 0.6-0.8 g/kg/day based on subject response and on advisory Exclusion Criteria: * Those on probiotic supplements in the past 3 months * Pregnancy, breast feeding or females of child-bearing potential who are unwilling to use a reliable form of contraception. * Immunosuppressant medications therapy specific to immune mediated renal diseases * HIV/AIDs * Underweight (BMI ≤ 18.5) * Subject with an infection that requires oral antibiotic administration at the time of randomization or close to that visit. * Those with gastrointestinal disease (irritable bowel syndrome or anal fissures or anal fistulas or perianal abscesses or perianal infections or diverticular diseases or colitis or colon polyps) at the time of screening and randomization, or within 6 months prior to the randomization visit (Visit 2) * Those with internal prosthesis including orthopedics, neurosurgery, heart valves, vascular stents ˂ 2 years post -surgery procedure. Those with Prosthesis \> 2 years should not be excluded. * Those with biological/tissue grafts or prosthesis or implant * Those on anticoagulant medicines, including Vit K antagonists (e.g., warfarin, coumadin) or the new class of oral anti-coagulants approved by FDA in the last 10 years * Those on peritoneal dialysis * Those with acute kidney injury * Those with mental conditions or medically debilitating disease/disorder other than CKD, which, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol or affect the ability to give informed consent or affect overall prognosis of the patient.

Study Info

Interventions

Locations Recruiting

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