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:

• Adults aged 18 to 75 years (men or women).
• For Part 1 only: People whose kidneys are working at a normal or near-normal level (no chronic kidney disease), based on a kidney function measurement called eGFR being 60 or above.
• For Part 2 only: People with moderate-to-severe chronic kidney disease (stages 3a, 3b, or 4) who are not yet on dialysis, with an eGFR between 15 and below 60.
• People with a high uric acid level in their blood (at or above 0.48 mmol/L when fasting), measured at specific points depending on whether the person is already taking uric acid-lowering medication.
• People with a body mass index (BMI) between 18 and 35.
• Women who could become pregnant must agree to use highly effective birth control methods, and avoid donating eggs, from the start of the study until 90 days after the last dose; their male partners must also agree to use birth control during this time.
• Men who are fertile must agree not to donate sperm and to use effective birth control from the start of the study until 90 days after the last dose; their female partners must also agree to use highly effective birth control during this time.
• People who are able to understand the study and sign a consent form, and are willing to follow all study procedures.
• For Part 2 only: People who need iron supplements for anaemia and have been on a stable iron treatment for at least 3 months, who agree to keep that treatment unchanged during the study.

Who may not be able to join:

• People who have received certain uric acid-breaking medications (such as Rasburicase or Pegloticase) within 2 weeks before the screening visit, or within a specific timeframe based on how long those drugs stay in the body.
• People who have had an acute gout flare requiring treatment within the 4 weeks before or during screening.
• People who have had major surgery within the 3 months before the first dose.
• People with a history of cancer (malignant tumours) within the past 6 months.
• People who have had a heart attack, angina, certain heart procedures, stroke, brain bleed, or a mini-stroke within the past 3 months.
• People currently taking other uric acid-lowering medications (such as allopurinol, febuxostat, probenecid, or benzbromarone) who are unable to stop taking them during the study, including the run-in period.
• People who need to start or change medications that can affect uric acid levels in the blood (such as certain blood pressure or water tablets) within at least 1 month before screening.
• People who have had certain stomach or bowel surgeries (such as gastric sleeve, colostomy, Roux-en-Y bypass, or gastric banding), unless a gastric band was removed at least 12 months before screening.
• People with a history of stomach or bowel problems including gastrointestinal bleeding, moderate-to-severe digestive problems, moderate-to-severe chronic constipation lasting at least 3 months, or a newly diagnosed stomach or duodenal ulcer within the past 4 weeks.
• People who have regularly received nutrition through a drip (parenteral nutrition) containing manganese within the past 3 months.
• People with a history of manganese poisoning or significant manganese exposure (for example, through work in mining, foundries, smelters, or battery manufacturing) within the past 2 months.
• People who are unable to swallow tablets.
• People who have taken part in another clinical trial or used an experimental drug or device within 30 days of signing the consent form.
• People with certain infections detected at screening, including HIV, syphilis, active hepatitis B (with virus levels above a certain threshold), or active hepatitis C (with virus levels above the normal range).
• People with a recent history of alcohol misuse, or who have consumed alcohol within 48 hours before the first dose, or who are unwilling to avoid alcohol during the study.
• People with uncontrolled high blood pressure (systolic blood pressure at or above 180 mmHg and/or diastolic at or above 110 mmHg) or poorly controlled diabetes (HbA1c at or above 9%) that has not responded to treatment.
• People whose high uric acid levels are caused by cancer, blood disorders, certain medications, or a genetic condition (rather than kidney disease).
• People who have had a kidney transplant or are planning to have one at the time of screening.
• People with abnormal bile or liver function, bile duct blockage, or gallstones at screening, or with certain liver enzyme or bilirubin levels that are too high at screening.
• People with a current or past condition causing reduced or blocked bile flow in the liver (cholestatic liver disease).
• People with a known serious allergic reaction to any ingredient in the study drug (IG3018 tablet).
• People whom the trial doctor considers unsuitable for participation for any other reason.

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