KT-301 Clinical Trial for CKD IV Patients

Suspended Phase 2,Phase 3 NCT05407389

Study Description

KT-301 is a probiotic formulation intended to improve gut bacteria balance and remove uremic toxins in patients with Chronic Kidney Disease (CKD) Stage IV. This open-label, multicenter, rollover extension study evaluates the long-term safety and efficacy of the live biotherapeutic product, KT-301, for CKD IV patients who completed the US-APR2020-01 study. Of the 30 million adults in the United States with CKD, most are undiagnosed. This clinical trial aims to provide evidence of a viable treatment option for this prevalent condition which costs Medicare beneficiaries over $79 billion and represents the ninth leading cause of death in the United States. Patients who completed the US-APR2020-01 study are eligible to enroll in this investigation.

Study Details

Registry ID:
NCT05407389
Conditions:
Chronic Kidney Disease stage4
Phase:
Phase 2,Phase 3
Target Enrollment:
600 participants
Start Date:
Age Range:
18–80 years
Healthy Volunteers:
No

Study Locations (5 sites)

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