Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

Launched by IPERBOREAL PHARMA SRL · Jun 20, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new peritoneal dialysis solution called XyloCore for patients with End Stage Renal Disease (ESRD). Peritoneal dialysis is a treatment that helps remove waste products from the blood when the kidneys can no longer do so effectively. The trial will compare XyloCore, which has low glucose, to standard glucose solutions currently used in treatment. The study involves different hospitals and will last for six months to see how well XyloCore works and if it is safe for patients.

To participate, you need to be at least 18 years old, have been diagnosed with ESRD, and have been on a specific type of dialysis called Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least the last three months. You should also be in stable health, without any serious issues or infections recently. If you join the trial, you can expect regular check-ins with the research team during the study period to monitor your health and how you respond to the new solution. It’s important to note that some people may not be eligible due to certain health conditions or treatments they are currently receiving. If you're interested, discussing this with your doctor can help clarify whether this trial is a good fit for you.

Gender

ALL

Eligibility criteria

• 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 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 exchange bag solution) for at least 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 three months
• • 9. Understanding the nature of the study and providing their informed consent to participation.
• 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 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. 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 menstrual cycle) 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-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.