Evaluation of Coated Aldehyde Oxystarch Xiqing for Reducing Protein-Bound Uremic Toxins in Adults with End-Stage Renal Disease on Dialysis

What this Trial Is About

This research aims to evaluate Coated Aldehyde Oxystarch Xiqing for reducing protein-bound uremic toxins PBUTs such as indoxyl sulfate and p-cresyl sulfate in adults with end-stage renal disease ESRD who are on dialysis. The study addresses the challenge that current dialysis treatments poorly clear these toxins, which are linked to adverse health outcomes. It is the first in vivo trial to investigate this oral adsorbents potential to lower PBUT levels in this patient population. Participants will take Coated Aldehyde Oxystarch orally, with a dosing schedule of 10 capsules each containing 0.625 g three times daily, totaling 18.75 g per day, for three months. During this period, they will continue their regular dialysis regimen. The study is a single-group interventional trial focusing on treatment evaluation. Throughout the study, participants will visit the clinic monthly for checkups and blood tests. Blood samples will be collected at baseline and monthly to measure levels of protein-bound uremic toxins and routine safety parameters. The primary outcome is the change in serum indoxyl sulfate levels after three months of treatment. Secondary outcomes include changes in serum phosphorus, calcium, potassium, inflammatory markers, and itch severity. The trial spans approximately three months of treatment with ongoing safety and efficacy monitoring.

Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease