Clinical Trial To Evaluate Safety And Efficacy Of US-APR2020 In Subjects With Chronic Kidney Disease Stage IV

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this Phase 2 study is to evaluate the safety and efficacy of the live biotherapeutic product, US-APR2020, in the management of patients with CKD Stage IV.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kibow Biotech Inc.; Kibow Pharma

Criteria

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 > 2.5 mg/mL

• Adherence to low protein diet (LPD) of 0.6-0.8 g/kg/day

Exclusion Criteria:

• Those on probiotics 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.

• 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)

• Those with internal prosthetics of any kind

• Those on anticoagulant medicines

• 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.