Status:
SUSPENDED
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
Lead Sponsor:
Kibow Pharma
Conditions:
Chronic Kidney Disease stage4
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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
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) a...
Eligibility Criteria
Inclusion
- Completion of US-APR2020-01 study
- Adults between the ages of 18-80 years
Exclusion
- 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
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05407389
Start Date
April 21 2022
End Date
March 1 2026
Last Update
September 19 2024
Active Locations (5)
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1
Jadedstone Clinical Research
Silver Spring, Maryland, United States, 20904
2
Kidney Michigan
Saginaw, Michigan, United States, 48604
3
South Carolina Clinical Research
Orangeburg, South Carolina, United States, 29118
4
Almeda Medical Clinic
Houston, Texas, United States, 77058