Phase 3 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:

• A parent or legal guardian must sign a consent form before any study-related assessments take place, and the child may also need to give their own agreement depending on their age and local rules.
• Children and teenagers aged 2 to under 18 years old at the start of the trial (Day 1).
• People whose kidneys are functioning at a level measured by a specific formula (called the modified Schwartz formula) showing a result of 30 or above, checked at the start and confirmed during a run-in period before the trial begins.
• People who have had a kidney biopsy confirming a diagnosis of primary IgA nephropathy (a kidney disease caused by a protein called IgA building up in the kidneys), with the biopsy taken within the last 3 years and showing less than 50% scarring and less than 25% of a specific type of damage called crescents — or where a new biopsy may be done if it is already part of the child's planned medical care.
• People who have had a consistently high level of protein in their urine (measured using a specific urine test called UPCR, showing a result of 1 g/g or above) across several measurements, despite being on the highest tolerated dose of a blood pressure and kidney-protecting medication (called an ACE inhibitor or ARB) for at least 120 days before the trial starts.
• People who have been on a stable dose of an ACE inhibitor or ARB for at least 120 days before the trial begins, and if also taking water tablets (diuretics), other blood pressure medications, or other kidney-related treatments, those doses must also have been stable for at least 120 days — people with allergies or intolerance to these medications may still be considered eligible (confirm with trial site).
• Children who weigh at least 10 kg at the screening visit and again on Day 1 of the trial.
• Parents or guardians who are able to communicate clearly with the research team and understand and follow the study's requirements on behalf of their child.

Who may not be able to join:

• People currently taking part in another clinical trial or who have taken an investigational (experimental) drug recently — the exact time period depends on the drug and local rules.
• People with a known allergy or bad reaction to the study drug or similar medications.
• People whose IgA nephropathy is caused by another underlying condition (called secondary IgAN), such as liver cirrhosis, coeliac disease, HIV, certain viral infections, inflammatory bowel disease, or a number of other listed conditions.
• People who have been diagnosed with IgA vasculitis (also known as Henoch-Schönlein purpura), a related condition involving a skin rash, joint pain, and abdominal pain.
• People who have a significant blockage or difficulty passing urine at the time of screening.
• People who have another kidney disease (other than IgA nephropathy) at the time of screening.
• People who have had a sudden episode of acute kidney injury within 4 weeks before screening.
• People whose kidney function has dropped by 50% or more within the 3 months before screening, or during the screening and run-in periods (a condition called rapidly progressive glomerulonephritis).
• People who have nephrotic syndrome (a serious kidney condition involving very high protein loss, low protein in the blood, and swelling) at the time of screening, based on the doctor's assessment.
• People with a specific heart marker in their blood (BNP) above 200 pg/mL at screening.
• People with low haemoglobin (below 9 g/dL, indicating significant anaemia) at screening, or who have needed a blood transfusion for anaemia in the 3 months before screening.
• People with a low platelet count (below 80,000/μL) at screening, which may affect blood clotting.
• People whose body weight on Day 1 falls below the minimum required for the group they were originally screened into, and where a lower weight group is not available for enrolment.
• People with a known history of a heart condition present from birth, heart failure, or significant fluid build-up in the body (such as fluid in the lungs, around the heart, or in the abdomen).
• People currently using herbal or homeopathic treatments for IgA nephropathy, including specific traditional herbal medicines such as Tripterygium wilfordii (Lei Gong Teng) and related herbs.
• People with a history of alcohol or illicit drug misuse within the past 3 years.
• People with blood pressure that is too high based on their age group — specific cut-off values apply depending on whether the child is aged 2–6, 6–12, or 12–18 years — or who have clinically significant low blood pressure at screening (confirm exact values with trial site).
• People who have recently been treated with immune-suppressing or immune-modifying medications (such as cyclophosphamide, rituximab, mycophenolate, oral budesonide, or corticosteroids above a certain dose) within 120 days (or 180 days for rituximab) before the trial starts, or who have taken a type of drug called an endothelin receptor antagonist (including sparsentan) within 120 days before starting.
• People who have had an organ transplant in the past (people who have had a corneal eye transplant are not excluded).
• People with serious ongoing health conditions, such as advanced heart disease, severe lung disease, or active liver disease, that the investigator believes would prevent safe participation.
• People with any other medical condition that the investigator believes would interfere with taking part in the study.
• People who have had an active bacterial, viral (including COVID-19), or fungal infection within 14 days before starting the study drug.
• People who have had a fever of 38°C (100.4°F) or above within 7 days before starting the study drug.
• People with a known HIV infection or who test positive for HIV at screening.
• People with active hepatitis B or hepatitis C infection, or with abnormal liver function test results above certain levels at screening.
• People who have had a cancer diagnosis in the past 5 years (with limited exceptions for certain skin or cervical conditions treated with curative intent) — for children aged 2 to under 5, this also includes any history of cancer diagnosed at birth or during early childhood.
• Female participants who are pregnant or breastfeeding.
• People currently taking any medications that are prohibited under the trial's rules.
• Female participants who are physically capable of becoming pregnant, unless a highly effective method of contraception (with a failure rate of less than 1% per year) is used during the trial and for 1 month after stopping the study treatment — acceptable methods include complete abstinence (as a consistent lifestyle choice), certain surgical procedures, hormonal contraception, or an intrauterine device (IUD), among others listed (confirm specific requirements with trial site).
• Male participants who are fertile must agree not to attempt to father a child or donate sperm during the trial and for at least 1 month after the last dose, and must agree to use a condom during the trial and for up to one month after the last dose if their partner is someone who could become pregnant.

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