ISRCTN16169961

Safety and efficacy of a new solution, XyloCore, for peritoneal dialysis

A study to evaluate the efficacy and safety of XyloCore, a glucose-sparing experimental solution, for peritoneal dialysis
Sintesi Research·ISRCTN Registry·procedure
Study focus
Disease/Condition
Chronic kidney disease
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Sintesi Research
Funder
Iperboreal Pharma
Location
Denmark,Germany,Israel,Italy,Spain,Sweden,United Kingdom
Timeline & enrollment
Phase
N/A
Start date
Apr 22, 2022
End date
Sep 01, 2024
Enrollment
170 participants
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
Chronic kidney diseaseChronic kidney disease, unspecifiedChronic kidney disease, stage 1Chronic kidney disease, stage 4Chronic kidney disease, stage 2
Data source
Registry
ISRCTN Registry
Trial ID
ISRCTN16169961
Type
Non-Device Trial
About this record

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.