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 with end-stage kidney disease (kidneys have stopped working) who need a new or replacement connection between an artery and vein (called an AV graft) in their arm to allow for dialysis treatment
• People aged 18 to 90 years old
• People whose arm anatomy is suitable for placing the graft in the upper arm or forearm, without crossing the elbow joint
• People who are able to take blood-thinning or anti-clotting medication after the procedure
• People who are willing and able to give their informed consent to participate
• People who are expected to live for at least one year
• People whose blood vessels (artery and vein) in the chosen arm are found to be suitable for the graft at the time of surgery, as assessed by the surgeon

Who may not be able to join:

• People with severe heart disease, such as serious heart failure or a high risk of heart attack, as judged by the treating doctor
• People with poorly controlled diabetes, for example those who have been hospitalised multiple times recently due to diabetes-related problems
• People being considered for the straight upper arm graft option where the distance between certain points on the arm measures less than 18 cm
• People with severe circulation problems (poor blood flow from arteries) in the arm chosen for the graft
• People with a known or suspected blockage or narrowing in the large veins in the chest on the same side as the planned graft
• People with low blood pressure at baseline, or who frequently have low blood pressure episodes during dialysis, which may increase the risk of the graft becoming blocked
• People with poorly controlled high blood pressure, for example those who have been hospitalised repeatedly for high blood pressure-related illness
• People with a blood haemoglobin level below 7 g/dL (a measure of red blood cells being very low)
• People with a platelet count (cells that help blood clot) that is either too low (below 50,000) or too high (above 500,000) per mm³
• People who have had a stroke within the 6 months before joining the trial
• People who have used another experimental drug or medical device within 30 days before joining the trial
• People who are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed during the study
• People who have had cancer that was active or treated within the past year, except for certain minor non-spreading skin cancers
• People with a weakened immune system, including those with HIV or AIDS, or those currently taking immune-suppressing medication for an active inflammatory condition or autoimmune flare (note: long-term, stable immunosuppressive therapy may be acceptable — confirm with trial site)
• People with a known or suspected condition that causes the blood to clot too easily
• People with a condition that causes unusual or excessive bleeding (other than bleeding problems associated with kidney failure)
• People with a documented history of a reaction called heparin-induced thrombocytopenia (HIT), where the blood thinner heparin has caused dangerous clotting (confirm with trial site)
• People with an active infection at the time of the procedure; if an infection has resolved, at least one week must have passed since recovery before the procedure can take place
• People who have a kidney transplant scheduled within the next 6 months
• People who, in the treating doctor's judgement, have any other condition that would make it difficult to properly assess the safety and effectiveness of the graft
• People who are unwilling or unable to attend all required follow-up visits and complete all study questionnaires

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