A Study to Evaluate the EffIcacy and Safety of XyloCore, a low-glucose solution for peritoneal dialysis
- Conditions
- End-Stage Renal Disease (ESRD)MedDRA version: 21.0Level: PTClassification code 10077512Term: End stage renal diseaseSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2019-004183-21-DK
- Lead Sponsor
- Iperboreal Pharma Srl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
Patients who meet all of the following criteria will be enrolled:
1.Age = 18 years
2.Diagnosed of ESRD and treated with CAPD in the last 3 months
3.In a stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalisation and major cardiovascular events
4.Have not experienced peritonitis episodes in the last 3 months
5.In treatment with Extraneal (nocturnal long-dwell exchange for at least one month);
6.In treatment with 1, 2 or 3 short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
7.Weekly Kt/V urea measurement > 1.7
8.Followed-up/treated by the participating clinical Center/Investigator in the last three months
9.Understanding the nature of the study and providing informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
Patients who fulfill any of the following criteria will not be enrolled:
1. History of drug or alcohol abuse in the six months prior to entering
the protocol
2. In treatment with androgens
3. Clinically significant abnormal liver function test (Gamma-GT and/or
AST and/or ALT > 24 UNL; and/or total bilirubin > 3 UNL
4. Acute infectious conditions (i.e.: pulmonary infection, acute
hepatitis, high or low tract urinary infections, renal parenchymal
infection, pericarditis, etc)
5. Expected patient's survival shorter than trial duration
6. L-Carnitine therapy in the month prior to entering the protocol
7. Have used any investigational drug in the 3 months prior to entering
the protocol
8. Female patients who are pregnant or breast-feeding.
9. Female patients of childbearing age (less than 24 months after the
last menstrual cycle) who do not use adequate contraception*
10. Patients affected by Primary Hyperoxaluria as per known medical
hystory
11. Patients with serum levels of uric acid > 7.2 mg/dl (male and
postmenopausal women) or > 6.0 mg/dl (premenopausal women)
12. Patients with a major cardiovascular event in the last 3 months
13. Patients with advanced cardiac failure (NYHA 4)
14. Hypersensitivity to any of the constituents of the study IMPs.
15. Any contraindication to the prescribed Peritoneal Dialysis solutions
(for long-dwell and short-dwell exchange) as per each product SmPC.
16. Participants with medical history of oxalate or lactate abnormalities
considered clinically significant by the investigator.
17. History or evidence of any other medical, neurological or
psychological condition that would expose the subject to an undue risk
of a significant AE or interfere with study assessments during the course
of the trial as determined by the clinical judgment of the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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. ;Secondary Objective: -Changes from the baseline values of LDL, HDL and total cholesterol, serum triglycerides, HbA1c (glycated haemoglobin) and insulin; <br>-Changes from the baseline values of hemoglobin and EPO requirements;<br>-Patients’ subjective assessment of fatigue (Chalder Fatigue Scale, see Appendix 2)<br>-Peritoneal Ultrafiltration<br>-Blood pressure<br>-Diuresis<br>-Residual kidney function <br>;Primary end point(s): The primary outcome measure is total weekly Kt/Vurea after a 24-week period using the assigned PD solution, assessed using a peritoneal function test.;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Changes from the baseline values of LDL, HDL and total cholesterol, serum triglycerides, HbA1c (glycated haemoglobin), and insulin; <br>-Changes from the baseline values of hemoglobin and EPO requirements;<br>-Patients’ subjective assessment of fatigue (Chalder Fatigue Scale, Appendix 2)<br>-Peritoneal Ultrafiltration<br>-Diuresis (or 24 hours urinary volume)<br>-Residual kidney function [measured as the arithmetic mean of urinary urea and creatinine clearance], Appendix 4 (Steubl 2019)<br>;Timepoint(s) of evaluation of this end point: 6 months