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KT-301 Extension in CKD Stage IV
NCT05407389Phase 3
Key facts
- Status
- Suspended
- Start
- Apr 2022
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- Kibow Biotech
- Modality
- Yeast Strains, Defined Consortia, Bacterial Strains
- Drugs
- KT-301
- Conditions
- chronic kidney disease (CKD)
01
Overview
Phase 3, open-label, single-arm trial of KT-301 in chronic kidney disease (CKD), sponsored by Kibow Biotech. Primary endpoints: Evaluate the long-term safety of KT-301 at 6 months and Evaluate the clinical efficacy of KT-301 at 6 months. Started Apr 2022; status: suspended.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
KT-301
Experimental: KT-301 (formerly US-APR2020)
03
Who it enrols
Adults aged 18-80 who completed the US-APR2020-01 study.
04
Endpoints
Primary
Evaluate the long-term safety of KT-301
Evaluate the clinical efficacy of KT-301
Secondary
Evaluate changes in basic blood uremic metabolic markers
Evaluate changes in complete blood count and hematology parameters
Reduction in C-Reactive Protein (CRP) levels
Modified SF36 QOL questionnaire
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