Phase 2 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 who are able to communicate clearly with the research team, understand the study requirements, and are willing to sign a consent form before any study procedures begin.
• People who are willing and able to attend scheduled visits and follow the treatment plan.
• People of either biological sex.
• People aged 35 to 75 years old at the time of signing the consent form.
• People with a diagnosis of chronic kidney disease (CKD) stage 3, with kidney function test results (eGFR) consistently between 30 and 59 mL/min/1.73 m², confirmed by at least 2 measurements in the past 3 months, and with consistently high levels of protein in the urine (a specific protein called albumin), also confirmed by multiple measurements including at the screening visit.
• People who are already being treated with the highest dose they can tolerate of certain blood pressure/kidney-protecting medications (ACE inhibitors or ARBs, and SGLT2 inhibitors), and whose dose has been stable for at least 3 months — unless those medications are not suitable for them. People who cannot take these medications may still be considered (confirm with trial site).
• People whose dose of GLP-1 receptor agonist medication (if they take one) has been stable for at least 3 months before screening.
• Women who are not breastfeeding, do not plan to become pregnant during the study, and are willing to use at least two FDA-approved forms of contraception throughout the study (such as permanent sterilisation, long-acting reversible contraceptives, contraceptive injection, short-acting hormonal methods, barrier methods, or emergency contraception).
• Men who agree to use contraception and not donate sperm during the study.

Who may not be able to join:

• People who have previously had any organ transplant (including bone marrow or stem cell transplants), or who have a kidney transplant planned in the next 6 months.
• People with very high levels of protein in the urine (above a certain threshold) or very low blood albumin levels.
• People who have had a heart attack, stroke, mini-stroke (TIA), or hospital admission for heart failure in the past 12 weeks, or who have poorly controlled or very low blood pressure at the screening visit.
• People with a history of cancer (other than certain successfully treated skin cancers) within the past 5 years.
• People with a history of atrial fibrillation (an irregular heart rhythm condition).
• People whose kidney disease is caused by a genetic (inherited) disorder.
• People with a history of systemic autoimmune conditions such as Type 1 diabetes, lupus (SLE), or kidney disease caused by an autoimmune condition.
• People who have had a sudden episode of acute kidney injury (a significant rapid worsening of kidney function) in the past 3 months.
• People who required dialysis for acute kidney failure within 12 weeks of the screening visit.
• People whose kidney function has declined rapidly (by 30% or more) over the past 3 months.
• People with a HbA1c (a blood sugar control measure) of 8.5% or higher.
• People with a BMI of 35 or higher.
• People with blood clotting disorders, a history of blood clots or clot-related events, or who are on long-term blood-thinning medication.
• People with a history of deep vein thrombosis (a blood clot in a deep vein).
• People with a history of acute pulmonary embolism (a blood clot in the lungs).
• People who have only one kidney.
• People who are currently taking, or have taken in the past 6 months, medications such as immunosuppressants, monoclonal antibodies, or anabolic steroids, or who use illicit drugs.
• People with a history of alcohol misuse or cigarette smoking in the past 6 months.
• People who are pregnant or breastfeeding at screening, or who plan to become pregnant or breastfeed during the study or follow-up period.
• People with a history of liver disease, significantly elevated liver enzyme levels, or positive test results for Hepatitis B, Hepatitis C, or HIV.
• People with a significant medical history or physical exam finding that, in the investigator's judgement, may interfere with the study.
• People with any active infection, including COVID-19, at the time of screening.
• People with any clinically significant lung disease.
• People with a known allergy or sensitivity to the study drug or any of its ingredients.
• People with a close personal or professional affiliation with the research site (for example, a close relative, employee, or student of the site).
• People who test positive for Panel Reactive Antibodies (PRA), which relates to certain immune system markers (confirm with trial site if unsure what this means).

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