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

Paused · Phase 2/Phase 3

Conditions studied: Chronic Kidney Disease stage4

In brief

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

Key facts

Study ID

NCT05407389

Run by

Kibow Pharma

People needed

600

Starts

2022-04-21

Expected to finish

2026-03-01

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…

• 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

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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