Health Condition 1: N184- Chronic kidney disease, stage 4 (severe)
Conditions
Interventions
Intervention1: US-APR2020: Live BioTherapeutic Product containing a mix of Streptococcus thermophilus (KB19), Lactobacillus acidophilus (KB27) and Bifidobacterium longum (KB31)
Duration of the trial i
Sponsors
Kibow Biotech Inc
CRO LifeSan Clinical Research a division of Centaur Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the safety and clinical efficacy of US-APR2020 in patients with Chronic Kidney Disease (CKD) Stage IV. Primary Endpoint: Presence of adverse events in less than 10% of the study population, as a measure of safety 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
| Measure | Time frame |
|---|---|
| Secondary Objective(s) Evaluate changes in basic blood uremic metabolic markers Evaluate changes in complete blood count and hematology parameters Evaluate changes in C-Reactive Protein (CRP) levels 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 | — |
Countries
Argentina, India, United States of America
Contacts
Public ContactMr Rajendra M Sawant
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt. Ltd.
Outcome results
None listed