Safety and efficacy of a new solution, XyloCore, for peritoneal dialysis - Trial ISRCTN16169961
Access comprehensive clinical trial information for ISRCTN16169961 through Pure Global AI's free database. This phase not specified trial is sponsored by Sintesi Research and is currently status unknown. The study focuses on Chronic kidney disease. Target enrollment is 170 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ISRCTN Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Sintesi Research
Iperboreal Pharma
Timeline & Enrollment
N/A
Apr 22, 2022
Sep 01, 2024
Summary
The primary objective of this study is to demonstrate the non-inferiority of XyloCore compared to the standard treatment of glucose PD solutions, with regards to the weekly Kt/Vurea. The study will also measure: 1. Changes from the baseline values of LDL, HDL and total cholesterol, serum triglycerides, HbA1c (glycated haemoglobin), and insulin 2. Changes from the baseline values of hemoglobin and EPO requirements (medication used to manage anemia in patients on dialysis) 3. Patients’ subjective assessment of fatigue (Chalder Fatigue Scale) 4. Peritoneal ultrafiltration 5. Diuresis (24 hours urinary volume) 6. Residual kidney function (measured as the arithmetic mean of urinary urea and creatinine clearance)
ICD-10 Classifications
Data Source
ISRCTN Registry
ISRCTN16169961
Non-Device Trial