Phase 3 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older
• People who have been diagnosed with end-stage kidney failure (where the kidneys no longer work) and have been treated with a specific type of home dialysis called CAPD (fluid-based dialysis through the abdomen) for the past 3 months
• People who have been in a stable health condition for the 3 months before screening, meaning no unplanned hospital stays and no major heart-related events during that time
• People who have not had a peritoneal dialysis-related infection (called peritonitis) in the last 3 months
• People who have been using a dialysis solution called Extraneal (used overnight) for at least 1 month as part of their prescribed treatment
• People whose prescribed daytime dialysis treatment uses one of several specific dialysis solutions (such as Phisioneal, Fixioneal, Dianeal, Balance, Bicavera, or similar products) at specific concentrations (confirm with trial site)
• People whose weekly dialysis adequacy measurement (called Kt/V urea) is above 1.7 at the start of the trial
• People who have been regularly seen and treated at the participating clinic for the last 3 months
• People who understand what the study involves and have given their written consent to take part

Who may not be able to join:

• People with a history of drug or alcohol misuse in the 6 months before entering the trial
• People currently being treated with androgens (a type of hormone therapy)
• People with significantly abnormal liver function test results, specifically a certain liver enzyme (gamma-GT) more than 4 times the upper normal level
• People who currently have an active infection, such as a lung infection, acute hepatitis, urinary tract infection, or inflammation around the heart, among others
• People whose life expectancy is expected to be shorter than the length of the trial
• People who have used L-Carnitine (a supplement or therapy) in the month before entering the trial
• People who have taken part in another clinical trial or used an experimental drug in the 3 months before entering this trial
• People who are pregnant or breastfeeding
• Women who could become pregnant (fewer than 24 months since their last menstrual period) and who are not using adequate contraception
• People diagnosed with a condition called Primary Hyperoxaluria (confirm with trial site)
• People with uric acid levels in the blood above certain thresholds — above 7.2 mg/dl for men and postmenopausal women, or above 6.0 mg/dl for premenopausal women
• People who have had a major heart-related event in the last 3 months
• People with severe heart failure classified at the most serious level (NYHA Class 4)
• People who have a known allergy or sensitivity to any ingredient in the study treatments
• People for whom any of the prescribed dialysis solutions used in the trial are medically unsuitable, according to the product guidelines
• People with a medical history of abnormal levels of oxalate or lactate that the doctor considers clinically significant
• People with any other medical, neurological, or psychological condition that the treating doctor believes could put them at undue risk or interfere with the study

Important: Always verify eligibility with the trial site directly before applying.