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:

• Adults aged 18 years or older
• People who have given their written consent to take part in the trial
• People who are willing and able to follow all trial procedures and attend all required visits for the full duration of the trial
• People who are able to communicate effectively with the trial team
• People who have end-stage kidney disease (kidneys have stopped working adequately)
• People who are suitable for a new blood vessel graft placed in the upper arm, and whose doctors expect them to need dialysis within 2 months (a previous failed access point at a different location is acceptable)
• People whose life expectancy is judged to be at least 2 years, taking into account their overall health and frailty
• People whose axillary vein (a large vein near the shoulder) measures approximately 7 mm or more in diameter
• People whose brachial artery (the main artery in the upper arm) measures approximately 4 mm or more in diameter
• People whose heart function meets acceptable levels, including adequate pumping output, normal-range lung artery pressure, and sufficient heart muscle function (confirm with trial site)
• People whose systolic blood pressure (the top number in a blood pressure reading) is 120 mmHg or higher
• People who have no narrowing of the central veins near the intended implant site, confirmed by ultrasound and/or imaging scan

Who may not be able to join:

• People who are unlikely or unable to follow the trial procedures or attend follow-up appointments
• People who are pregnant
• People who have received peritoneal dialysis (a type of dialysis using the abdomen) within the last 2 months
• People who have a central venous catheter (a tube inserted into a large vein) on the same side of the body as the planned implant
• People with clinically defined severe obesity (a BMI above 40)
• People with physical characteristics of the blood vessels that make the procedure unsuitable, including any issues found during surgery when the vessels are examined
• People with an immune deficiency condition
• People with a history of abnormal blood clotting or bleeding disorders
• People with an unusually high platelet count (above 1 million platelets per microlitre of blood)
• People with a history of a serious reaction to heparin (a blood-thinning medication) that caused a drop in platelets
• People with confirmed narrowing or damaged valves in the veins near the planned implant site
• People with insufficient blood flow or pressure in the artery near the planned implant site
• People currently participating in another clinical trial of an investigational drug or device that could affect this trial's results
• People with a fever above 38°C
• People with a known allergy to silicone, or an allergy to imaging contrast dye that cannot be treated
• People with a confirmed or suspected bacterial, viral, or parasitic infection within the 8 weeks before the graft procedure, or ongoing infection symptoms
• People with uncontrolled or poorly controlled diabetes
• People with a history or signs of severe heart disease
• People with any other condition that the trial investigator considers would affect their safety or the reliability of the trial results

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