Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study

An Open-Label Rollover Extension Phase 2 Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study

This is an Open-Label Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of KT-301 (formerly US-APR2020) in Subjects With CKD IV Who Completed the US-APR2020-01 Study

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease stage4
• Intervention / Treatment: Drug: KT-301 (formerly US-APR2020)

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) and most are undiagnosed. In addition, CKD represents the ninth leading cause of death in the United States. Kidney diseases also represent great socioeconomical cost worldwide. In the United States, treating Medicare beneficiaries with CKD costed over $79 billion, and treating people with End Stage Kidney Disease (ESKD) costed an additional $35 billion in 2016. To date, there is no cure for CKD.

CKD is accompanied by altered pathogenic gut bacteria, inflammation, and accumulation of uremic toxins in the blood. These blood uremic toxins can diffuse passively into the bowel. Scientific research has shown that probiotic bacteria could metabolize various uremic toxins such as urea, uric acid and creatinine. In addition, by supplementing the gut microbiome with probiotic bacteria, it is possible to metabolize the nitrogenous waste products and other toxins which diffuse into the gut, and thus lower levels of inflammation and blood uremic toxins.

KT-301 (formerly US-APR2020) is a probiotic formulation of bacteria intended to restore the gut bacteria balance to improve the removal of uremic toxins in the bowel in CKD patients.

This is an open label, multicenter, rollover extension study to provide KT-301 to subjects who were previously enrolled into and completed the placebo-controlled study, US-APR2020-01. Subjects will roll over to the long-term extension study at the last visit of the US-APR-2020-01 study. All subjects who completed the US-APR2020-01 study will be eligible to enroll in this study.

The purpose of this open-label study is to evaluate the long-term safety and efficacy of the live biotherapeutic product, KT-301, in the management of patients with CKD Stage IV.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Mukesh Kumar; Phone Number: 2407504893; Email: mkumar@fdamap.com

Study Locations

• United States
  • Maryland
    • Silver Spring, Maryland, United States, 20904
      • Recruiting
      • Jadedstone Clinical Research
      • Contact: Mukesh Kumar; Phone Number: 240-750-4893; Email: mkumar@fdamap.com
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Recruiting
      • Kidney Michigan
      • Contact: Mukesh Kumar; Phone Number: 240-750-4893; Email: mkumar@fdamap.com
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Recruiting
      • South Carolina Clinical Research
      • Contact: Mukesh Kumar; Phone Number: 240-750-4893; Email: mkumar@fdamap.com
  • Texas
    • Houston, Texas, United States, 77058
      • Recruiting
      • Almeda Medical Clinic
      • Contact: Mukesh Kumar; Phone Number: 240-750-4893; Email: mkumar@fdamap.com
  • Virginia
    • Woodbridge, Virginia, United States, 22192
      • Recruiting
      • Mendez Center for Clinical Research
      • Contact: Mukesh Kumar; Phone Number: 240-750-4893; Email: mkumar@fdamap.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Completion of US-APR2020-01 study
• Adults between the ages of 18-80 years

Exclusion Criteria:

• Did not participate in the placebo-controlled study US-APR2020-01
• Withdrew from US-APR2020-01 study prior to completing the 6 months treatment for any reason
• Unwilling or unable to visit the site for the follow-up visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KT-301 (formerly US-APR2020)	Drug: KT-301 (formerly US-APR2020); KT-301 (formerly US-APR2020) will be administered orally at 2 capsules per day (a total dose of 90 Billion CFUs per day of the Live BioTherapeutic).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the long-term safety of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV	Presence of adverse events in less than 10% of the study population, as a measure of safety Chronic Kidney Disease (CKD) Stage IV	6 months
Evaluate the clinical efficacy of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV	Arresting the decline of eGFR as per NKF-USFDA guidelines following date of roll- over transition until study competition, compared to baseline (End of study for US- APR2020-01) as a measure of clinical efficacy	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate changes in basic blood uremic metabolic markers	6 months
Evaluate changes in complete blood count and hematology parameters	6 months
Reduction in C-Reactive Protein (CRP) levels following date of roll-over transition until study competition	6 months
Percent change in rating scale (Modified SF36 QOL questionnaire) from roll-over transition until study competition (at 24-weeks)	6 months

Collaborators and Investigators

• Sponsor: Kibow Pharma

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: US-APR2020-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No