Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

INCLUSION CRITERIA:

1. Age ≥18 years

2. Diagnosed with ESRD and treated with CAPD in the last 3 months

3. In stable clinical condition during the 3 months before screening as demonstrated bythe absence of non-elective hospitalization and major cardiovascular events

4. Have not experienced peritonitis episodes in the last 3 months

5. In treatment with prescribed Extraneal (nocturnal exchange bag solution) for atleast 1 month

6. In treatment with 1, 2 or 3 diurnal exchange bag solution of prescribed Phisioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27%or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.25%, 2.3%, 4.5%glucose)

7. Kt/V urea measurement > 1.7 per week at Baseline Visit

8. Followed/treated by the participating clinical Center/Investigator in the last threemonths

9. Understanding the nature of the study and providing their informed consent toparticipation.

EXCLUSION CRITERIA:

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 (ɣ-GT > 4 times the upper normallimit)

4. Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or lowurinary tract infections, renal parenchymal infection, pericarditis, etc)

5. Expected patient's survival shorter than the trial duration

6. History of L-Carnitine therapy or use 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 menstrualcycle) who do not use adequate contraception

10. Patients affected by Primary Hyperoxaluria as per known medical therapy

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-dwelland short-dwell exchange) as per each product SmPC.

16. Participants with medical history of oxalate or lactate abnormalities consideredclinically significant by the investigator.

17. History or evidence of any other medical, neurological or psychological conditionthat would expose the subject to an undue risk of a significant AE or interfere withstudy assessments during the course of the trial as determined by the clinicaljudgment of the investigator.