Global Phase 2 clinical trial to Evaluate Safety And Efficacy Of US-APR2020 In Subjects With Chronic Kidney Disease Stage IV

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Adults between the ages of 18–80 years

2.CKD Stage IV with decling kidney function for a period more than 6 months

3.Serum Creatinine more than 2.0 mg/mL

4.Adherence to low protein diet (LPD) of 0.6–0.8 g/kg/day based on subject response and on advisory

Exclusion Criteria

1.Those on probiotic supplements in the past 3 months

2.Pregnancy, breast feeding or females of child-bearing potential who are unwilling to use a reliable form of contraception.

3.Immunosuppressant medications therapy specific to immune mediated renal diseases

4.HIV/AIDs

5.Underweight (BMI = 18.5)

6.Subject with an infection that requires oral antibiotic administration at the time of randomization or close to that visit.

7.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)

8.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.

9.Those with biological/tissue grafts or prosthesis or implant

10.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

11.Those on peritoneal dialysis

12.Those with acute kidney injury

13.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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the safety and clinical efficacy of US-APR2020 in patients with Chronic Kidney Disease (CKD) Stage IV. <br/ ><br>Primary Endpoint: <br/ ><br>Presence of adverse events in less than 10% of the study population, as a measure of safety <br/ ><br>Arresting the decline of eGFR as per NKF-USFDA guidelines in the group treated with US-APR2020 as compared to the placeboTimepoint: US-APR2020 or placebo 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). Subjects will be followed for 6 months. Time points: Visit 1: Screening (Day -30 to -1), Visit 2: Day 1 first dose, Visit 3: Day 8 Follow up 1, Visit 4: Day 30 Follow up 2, Visit 5: Day 60 Follow up 3, Visit 6: Day 90 Follow up 4, Visit 7: Day 180 End of trial

Secondary Outcome Measures

Name	Time	Method
Secondary Objective(s) <br/ ><br>Evaluate changes in basic blood uremic metabolic markers <br/ ><br>Evaluate changes in complete blood count and hematology parameters <br/ ><br>Evaluate changes in C-Reactive Protein (CRP) levels <br/ ><br>Quantify improvement in quality of life (QOL)Timepoint: Time points: Visit 1: Screening (Day -30 to -1), Visit 2: Day 1 first dose, Visit 3: Day 8 Follow up 1, Visit 4: Day 30 Follow up 2, Visit 5: Day 60 Follow up 3, Visit 6: Day 90 Follow up 4, Visit 7: Day 180 End of trial