Abstract: FR-OR040
CKD-Specific Probiotic Strain KT-301 Significantly Slows Progression in Stage 4 CKD: Results of a Randomized, Double-Blind, Phase 2b Study
Session Information
- Exciting Developments in CKD Research: From Diagnostics to Management and More
October 23, 2026 | Location: Mile High Ballroom 1D, Convention Center
Abstract Time: 05:00 PM - 05:10 PM
Category: CKD (Non-Dialysis)
- 2202 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Segal, Robert, Kibow Biotech, Exton, Pennsylvania, United States
- Anteyi, Emmanuel Ada, Kibow Biotech, Exton, Pennsylvania, United States
- Fadem, Stephen Z., Baylor College of Medicine, Houston, Texas, United States
- Johnson, Richard J., University of Denver, Denver, Colorado, United States
Group or Team Name
- on behalf of the KT-301 CKD 4 Study Investigators
Background
Gut microbiome dysbiosis in CKD contributes to accumulation of uremic toxins, impaired intestinal barrier function, endotoxemia, systemic inflammation, and progressive loss of kidney function. Modulating the microbiome with probiotic strains designed to address CKD dysbiosis may offer a novel therapeutic approach in advanced CKD patients for whom treatment options remain limited.
Methods
In this randomized, double-blind, phase 2b trial, stage 4 CKD patients (eGFR 15-29 mL/min/1.73 m2) were assigned to KT-301, a 3-strain probiotic formulation containing 45 billion colony-forming units plus prebiotic fibers, or placebo, administered orally twice daily with meals for 6 months. This was followed by a 6-month open-label extension, during which all patients received KT-301. The primary endpoint was change in creatinine-based eGFR slope using CKD-EPI (2021) methodology. Prespecified secondary endpoints included progression to symptomatic (Stage 5) ESRD, cystatin C- and combined creatinine-cystatin C eGFR, BUN, uric acid, high-sensitivity C-reactive protein, microalbuminuria, and quality-of-life measures.
Results
Among 370 randomized patients with stage 4 CKD, treatment with KT-301 (n=187) resulted in a significantly slower decline in kidney function over 6 months compared with placebo (n=183). Using a Mixed Model for Repeated Measures analysis, the between-group difference in creatinine-derived eGFR change was 1.13 mL/min/1.73 m2 (p=0.0118). Mean eGFR at 6 months was 21.53 vs 20.64 mL/min/1.73 m2 (baseline 21.78 and 22.16, respectively). Progression to ESRD was numerically lower in the intent-to-treat population and significantly lower in the per-protocol population (10.0% vs 19.1%, p=0.0356). In the per-protocol analysis, the between-group eGFR difference at the final visit also favored KT-301 (p=0.0076). Analyses using combined creatinine- and cystatin C-based eGFR supported these findings. Continued benefit was observed during the open-label extension. KT-301 was well-tolerated compared with placebo.
Conclusion
In this randomized, double-blind trial, KT-301 significantly slowed eGFR decline over 6 months in stage 4 CKD, with a consistent signal toward reduced progression to kidney failure. These results represent the first demonstration that targeted probiotic intervention can benefit advanced CKD and support the gut-kidney axis as a therapeutic target.
Acknowledgment
Natarajan Ranganathan (in memoriam) and Usha Vyas (Kibow Biotech, LLC), and Mukesh Kumar, Amrita Reddy and Mukerjee Bhaswati (FDAMap Clinical)
Funding
- Commercial Support – Kibow, Biotech, LLC