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

NCT04913272 | Suspended Phase 2 FDA Drug

• 1 other identifier: US-APR2020-01
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Kidney Disease stage4

Outcome Measures

Primary Outcomes (2)

• Evaluate incidences of Treatment-Emergent Adverse Events following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of safety.

  Presence of adverse events in less than 10% of the study population, as a measure of safety

  six months

• Evaluate the change of eGFR as per NKF-USFDA guidelines following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of clinical efficacy.

  Arresting the change of Estimated glomerular filtration rate (eGFR) as per National Kidney Foundation- US Food and Drug Administration (NKF-USFDA )guidelines in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo, as a measure of efficacy.

  six months

Secondary Outcomes (4)

• Evaluate changes in basic blood uremic metabolic markers

  six months

• Evaluate changes in complete blood count and hematology parameters

  six months

• Evaluate changes in C-Reactive Protein (CRP) levels

  six months

• Evaluate change in quality of life (QOL)- SF36 QOL questionnaire

  six months

Study Arms (2)

KT-301 (formerly US-APR2020)

EXPERIMENTAL

Patients in this group will be administered KT-301 (formerly US-APR2020) orally at 2 capsules per day for six months. The frequency will be one capsule in the morning and one capsule in the evening, after meals, (for a total daily dose of 90 Billion CFUs).

Drug: US-APR2020

Placebo

PLACEBO COMPARATOR

Patients in this group will be administered placebo orally at 2 capsules per day for six months. The frequency will be one capsule in the morning and one capsule in the evening, after meals.

Drug: Placebo

Interventions

US-APR2020 DRUG

US-APR2020 capsules 45 billion CFUs of the LBT.

KT-301 (formerly US-APR2020)

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kibow Pharma: lead

Study Sites (5)

Jadedstone Clinical Research

Silver Spring, Maryland, 20904, United States

Location

Kidney Michigan

Saginaw, Michigan, 48604, United States

Location

South Carolina Clinical Research

Orangeburg, South Carolina, 29118, United States

Location

Almeda Medical Clinic

Houston, Texas, 77058, United States

Location

Mendez Center for Clinical Research

Woodbridge, Virginia, 22192, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter clinical trial to evaluate the safety and efficacy of KT-301 (formerly US-APR2020) in patients with CKD Stage IV. Following Screening and Enrollment, patients will be Randomized to either Group KT-301 or Placebo. In Group KT-301, the drug KT-301 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) for six months. Subjects will be followed for 6 months. Patients in Placebo Group will be administered Placebo tablets in similar routine.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 4, 2021
• Study Start: June 24, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (5)