Rationale and design of ELIXIR, a randomized, controlled trial to evaluate efficacy and safety of XyloCore, a glucose-sparing solution for peritoneal dialysis
Abstract
Peritoneal dialysis adoption and technique survival is affected by limitations related to peritoneal membrane longevity and metabolic alterations. Indeed, almost all peritoneal dialysis fluids exploit glucose as an osmotic agent that rapidly diffuses across the peritoneal membrane, potentially resulting in metabolic abnormalities such as hyperglycemia, hyperinsulinemia, obesity, and hyperlipidemia. Moreover, glucose-degradation products generated during heat sterilization, other than glucose itself, induce significant morphological and functional changes in the peritoneum leading to ultrafiltration failure. The partial substitution of glucose with osmotic agents characterized by a better local and systemic biocompatibility has been suggested as a potential strategy to innovate peritoneal dialysis fluids. The approach aims to minimize glucose-associated toxicity, preserving the peritoneal membrane welfare and counteracting common comorbidities. In this work, we report the clinical trial design of ELIXIR, a phase III randomized, controlled, blinded outcome assessment study comparing Xylocore®, an innovative formulation based on Xylitol and l-carnitine, to standard glucose-based regimens, in end-stage kidney disease patients treated with continuous ambulatory peritoneal dialysis; 170 patients will be randomized (1:1) to receive XyloCore® or to continue their pre-randomization peritoneal dialysis (PD) therapy with glucose-only PD solutions, for 6 months. The primary study's…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 170 participants or records.
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