Triomed AB today announced positive results from a prospective, multicenter, randomized, crossover study evaluating steady concentration peritoneal dialysis using the Carry Life UF system in adult patients undergoing CAPD. The study demonstrated significant improvements in ultrafiltration, peritoneal sodium removal and glucose ultrafiltration efficiency (ultrafiltration volume in relation to glucose absorption) compared with standard 2.5% dextrose CAPD in the home setting over four weeks. The study results were presented as a Focussed Oral presentation based on a late-breaking clinical trial abstract at the European Renal Association (ERA) Congress in Glasgow, United Kingdom, and simultaneously published in the Journal of the American Society of Nephrology (JASN).
In this study, participants received their standard CAPD treatment during the control arm, whereas in the Carry Life UF arm, one daily 2.5% dextrose exchange was replaced by a Carry Life UF treatment three days per week, and by a 1.5% dextrose CAPD exchange on the remaining four days. A total of 19 participants completed the study (mean age 56 years, six women, seven participants had diabetes).
The ultrafiltration volume primary endpoint was met, with Carry Life UF demonstrating superiority over control by exceeding the prespecified superiority margin of 250 mL. The mean increase in ultrafiltration volume was 381 mL (95% CI, 285 to 477), with a mean ultrafiltration volume of 513 mL for the Carry Life UF total group compared with 132 mL for the control. Carry Life UF also resulted in greater peritoneal sodium removal compared with control, with a mean increase of 43 mmol per exchange (95% CI, 32 to 54), reflecting a mean of 48 mmol per exchange with Carry Life UF versus 5.5 mmol with control. Glucose ultrafiltration efficiency was more than twice that of control, indicating that increased peritoneal fluid removal can be achieved with lower glucose absorption. The adverse event profile observed in the study was reassuring, with no unexpected safety signals and similar frequency in two study arms.
“Steady concentration peritoneal dialysis delivered with the Carry Life UF system has the potential to enable a step change in the prescription of peritoneal dialysis, reducing the need for hypertonic dextrose solutions while delivering effective ultrafiltration and peritoneal sodium removal,” said Associated Professor Olof Heimbürger, Senior Nephrologist at Karolinska Institutet, Stockholm, Sweden. “Fluid overload remains one of the most important challenges in peritoneal dialysis, affecting a large proportion of patients and contributing to increased morbidity and mortality. The Carry Life UF system may offer a new approach to reduce uncontrolled fluid overload and the risk of transition to hemodialysis.”
“Triomed is using these findings to support ongoing regulatory applications in Europe for the Carry Life UF system, while planning a registry study as part of post-market clinical follow-up to further evaluate steady concentration peritoneal dialysis in real-world clinical practice, and further a pediatric investigation as required by the European Medicines Agency,” said Mats Wahlström, Chairman of the Board of Triomed. “We are extremely grateful to the Triomed team for their tireless efforts in advancing this technology, and to the investigators for their rigorous work in conducting the study, as well as to all our dedicated investors for their continued long-term support in enabling the development of this breakthrough innovation.”
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