Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

Korábbi kezelés

• History of drug or alcohol abuse in the six months prior to entering the protocol
• In treatment with androgens
• History of L-Carnitine therapy or use in the month prior to entering the protocol
• Have used any investigational drug in the 3 months prior to entering the protocol
• Patients affected by Primary Hyperoxaluria as per known medical therapy

Más betegség

• Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
• Patients with advanced cardiac failure (NYHA 4)
• Hypersensitivity to any of the constituents of the study IMPs.
• Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator.
• 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.

Laborértékek

• Patients with serum levels of uric acid \> 7.2 mg/dl (male and postmenopausal women) or \> 6.0 mg/dl (premenopausal women)

Életkor

• Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception

Egyéb

• Clinically significant abnormal liver function test (ɣ-GT \> 4 times the upper normal limit)
• Expected patient's survival shorter than the trial duration
• Female patients who are pregnant or breast-feeding.
• Patients with a major cardiovascular event in the last 3 months
• Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC.

• Age ≥18 years
• Diagnosed with ESRD and treated with CAPD in the last 3 months
• In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events
• Have not experienced peritonitis episodes in the last 3 months
• In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month
• 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)
• Kt/V urea measurement \> 1.7 per week at Baseline Visit
• Followed/treated by the participating clinical Center/Investigator in the last three months
• Understanding the nature of the study and providing their informed consent to participation.