Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV

Paused · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease stage4

In brief

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.

Key facts

Study ID

NCT04913272

Run by

Kibow Pharma

People needed

630

Starts

2021-06-24

Expected to finish

2025-12-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Jadedstone Clinical Research — Silver Spring, Maryland, United States
• Kidney Michigan — Saginaw, Michigan, United States
• South Carolina Clinical Research — Orangeburg, South Carolina, United States
• Almeda Medical Clinic — Houston, Texas, United States
• Mendez Center for Clinical Research — Woodbridge, Virginia, United States

Full record on ClinicalTrials.gov

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