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

Not Applicable

• Conditions: Chronic kidney disease; Urological and Genital Diseases

• Registration Number: ISRCTN16169961
• Lead Sponsor: Sintesi Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-28
• Last Update Posted: 6 November 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Age =18 years
2. Diagnosed with end-stage renal disease (ESRD) and treated with continuous ambulatory peritoneal dialysis (CAPD) in the last 3 months
3. In stable clinical condition during the 3 months before screening as demonstrated by the 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 long-dwell exchange) for at least 1 month
6. In treatment with 2 or 3 diurnal short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal, Dianeal low calcium (1.36%, 2.27% or 3.86% glucose), Balance, Bivavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
7. Weekly Kt/V urea measurement =1.7 (See Annex 1)
8. Followed/treated by the participating clinical Center/Investigator in the last 3 months
9. Understanding the nature of the study and providing their informed consent to participate in the study

Exclusion Criteria

1. History of drug or alcohol abuse in the 6 months prior to entering the protocol
2. In treatment with androgens
3. Clinically significant abnormal liver function test (Gamma-GT >4 times the upper normal limit)
4. Acute infectious conditions (i.e. pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
5. Expected patient’s survival shorter than the 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 breastfeeding
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 history
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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified