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

NCT05407389 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: US-APR2020-02
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Chronic Kidney Disease stage4

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

KT-301 (formerly US-APR2020)

EXPERIMENTAL

Drug: KT-301 (formerly US-APR2020)

Interventions

KT-301 (formerly US-APR2020) DRUG

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).

KT-301 (formerly US-APR2020)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an extension open-label multicenter study to evaluate the long-term safety and efficacy of KT-301 (formerly US-APR2020) in patients with CKD Stage IV. KT-301 will be administered orally at 2 capsules per day (a total dose of 90 Billion CFUs per day of the Live BioTherapeutic).

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 7, 2022
• Study Start: April 21, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (5)