Status:
SUSPENDED
Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV
Lead Sponsor:
Kibow Pharma
Conditions:
Chronic Kidney Disease stage4
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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) a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT04913272
Start Date
June 24 2021
End Date
December 1 2025
Last Update
September 19 2024
Active Locations (5)
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1
Jadedstone Clinical Research
Silver Spring, Maryland, United States, 20904
2
Kidney Michigan
Saginaw, Michigan, United States, 48604
3
South Carolina Clinical Research
Orangeburg, South Carolina, United States, 29118
4
Almeda Medical Clinic
Houston, Texas, United States, 77058