Phase 2 Chronic Kidney Disease Trial, Recruiting

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

Who might be able to join this trial:

Phase I (healthy volunteers):

• Adults between 18 and 55 years old at the time of signing the consent form.
• People with a body weight between 45 kg and 110 kg, and a BMI between 18.0 and 30.0.
• People who are generally healthy, with no significant ongoing illnesses or regular medications (beyond what the trial specifically allows), as determined by the trial doctor.

Phase IIa (patients with kidney disease):

• Adults aged 18 or older at the time of signing the consent form.
• People who have been diagnosed with end-stage kidney disease (kidneys have permanently stopped working well enough on their own).
• People whose main method of dialysis access is through a tunneled central venous catheter (a tube placed into a large vein, usually in the chest or neck).
• People who have been receiving hemodialysis (a machine-based blood-cleaning treatment) for at least 90 days before joining the trial.
• People who have had at least 3 dialysis sessions using their current dialysis filter.
• People whose dialysis is working adequately, based on a specific measurement (called single-pool Kt/V, greater than 1.2) taken within the past 30 days (confirm with trial site).
• People who have not started any brand-new medications in the 2 weeks before receiving the trial treatment (dose adjustments to existing medications are allowed).
• People who are not currently taking long-term antibiotic tablets or injections that target a specific type of bacteria called Staphylococcus aureus.

Who may not be able to join:

Phase I:

• People with a known allergy to any ingredient in the trial treatment.
• People who have previously had an allergic reaction, an infusion-related reaction, or a serious bad reaction to a type of medicine called a monoclonal antibody.
• People with a significant bleeding or clotting disorder, or a history of unusual bleeding or bruising from injections or blood draws.
• People with certain liver enzyme levels (AST or ALT) above 1.5 times the upper limit of the normal range at the screening stage.
• People whose kidneys are not working at full capacity, based on a specific kidney function measurement (eGFR below 90 mL/min/1.73 m²) at the screening stage.
• People with haemoglobin (a measure of red blood cells) or platelet counts (cells that help blood clot) below the normal range at screening.
• People with white blood cell counts outside the normal range, unless the trial doctor judges this to be due to normal variation by ethnicity.
• People who have had a cancer diagnosis in the past 5 years, other than certain treated skin cancers or locally treated cervical cancer.
• People with any other blood test result that the trial doctor considers significant or that might affect the study results.
• People with a significant abnormality found on a heart tracing (ECG) at screening, as determined by the trial doctor.
• People who have an acute illness, including a fever of 38°C (100.4°F) or higher, on the day before or the day of the planned dose (though a person excluded for this reason may be eligible to receive the dose if the illness clears within the 28-day screening period).
• People with a known or suspected immune system deficiency, or those who have been taking immune-suppressing medicines — including steroid tablets (such as prednisone at 20 mg or more daily, for more than 2 weeks) — within the 6 months before screening.
• People with conditions that may cause the body to remove the trial treatment more quickly than expected, such as severe gut conditions that cause protein loss, or those undergoing a blood plasma exchange procedure.
• People who have had more than 450 mL of blood drawn (for any reason) in the 2 months before screening.
• People who do not have suitable veins for blood tests and receiving the trial treatment.
• People with any other condition that the trial doctor considers a safety concern or that could affect the trial results.

Phase IIa:

• People with a known allergy to any ingredient in the trial treatment.
• People with a history of allergic conditions that may be made worse by ingredients in the trial treatment.
• People who have previously had an allergic reaction, an infusion-related reaction, or a serious bad reaction to a monoclonal antibody medicine.
• People with a haemoglobin level below 9 g/dL at screening, if the trial doctor considers this to be due to an acute (short-term) condition.
• People with a blood protein level (serum albumin) below 3 g/dL at screening, if the trial doctor considers this to be due to an acute (short-term) condition.
• People who have had a heart attack, a serious heart event, a stroke, a seizure, or a blood clot (such as a clot in a deep vein or the lungs, not including a clot in dialysis access) within the 90 days before joining the trial.
• People who have had a known Staphylococcus aureus (a type of bacterial) infection within 90 days of entering the study.
• People who have had a known acute viral or bacterial infection, or symptoms suggesting one, within the 21 days before receiving the trial treatment (a mild illness with a temperature of 38.1°C or less may not require exclusion, at the trial doctor's judgement).
• People who currently have cancer and are receiving chemotherapy.
• People who have a scheduled date for a living donor kidney transplant.
• People who plan to switch from hemodialysis to a different type of dialysis (called peritoneal dialysis) within the main study period of 181 days.
• People who have a scheduled date to switch to a type of dialysis access called an arteriovenous graft, or who already have one being prepared for use.
• People who have a scheduled date to switch to a type of dialysis access called an arteriovenous fistula, or who already have one being prepared and expected to be in use within 90 days.

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