Comparison of Kirpa Kit™ manual hemodialysis device to standard continuous kidney replacement therapy in vitro

Access to kidney replacement therapy remains limited in many low- and middle-income countries. The Kirpa Kit™ is a low-cost, electricity-free manual hemodialysis device designed for resource-limited settings. Although it has previously shown feasibility in vitro, in vivo, and in first-in-human use, it has never been directly compared with an automated extracorporeal dialysis platform under matched conditions.

In vitro experiments were performed in triplicate comparing the Kirpa Kit™ and the Prismaflex™. A 5-L bag of diluted packed red blood cells enriched with urea was used for each device across all runs. Each system was operated for 30 min per experiment at a blood flow rate of ~ 100 mL/min and a dialysis fluid flow rate of 4 L/h. Blood urea nitrogen (BUN) was measured at baseline and every 10 min. UF target was 0 mL.

Median BUN reduction at 10, 20, and 30 min was 7.1%, 13.6%, and 18.0% for the Kirpa Kit™ and 8.2%, 16.4%, and 23.2% for the Prismaflex™, respectively. Final BUN reduction did not differ between devices (p = 0.38). Median achieved cumulative UF volume per experiment with a goal target of 0 mL was 16 mL (IQR 14-28) for the Kirpa Kit™ and 61 mL (IQR 54-62) for the Prismaflex™. Manual operation of the Kirpa Kit™ was feasible throughout the experiments, with only mild operator fatigue.

Under controlled experimental conditions, the Kirpa Kit™ achieved BUN reduction comparable to a standard automated CKRT platform, supporting its potential as a low-cost dialysis option for infants, children, adolescents, and adults in resource-limited settings.