This clinical trial is focused on studying a condition called Immunoglobulin A Nephropathy (IgAN), which affects the kidneys. The study will evaluate a treatment called ravulizumab, also known by its code name ALXN1210, to see if it can help preserve kidney function in adults with IgAN. Ravulizumab is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.
The purpose of the study is to assess how effective ravulizumab is compared to a placebo in reducing the amount of protein in the urine, a condition known as proteinuria, and in slowing down the decline of kidney function over time. Participants in the study will receive either ravulizumab or a placebo, and their kidney function will be monitored throughout the study period. The study will involve regular check-ups and assessments to track changes in kidney health and overall well-being.
Participants will be involved in the study for a period of time, during which they will receive the treatment and undergo various tests to measure the effects on their kidney function. The study aims to provide valuable information on whether ravulizumab can be a beneficial treatment option for people with IgAN, potentially leading to better management of the disease and improved quality of life for those affected.
1joining the study
Upon joining the study, the participant must be at least 18 years old and have a confirmed diagnosis of immunoglobulin A nephropathy (IgAN) through a kidney biopsy.
The participant must have controlled blood pressure and meet specific criteria related to kidney function and protein levels in urine.
Vaccination against meningococcal infection is required, and if done less than two weeks before the study starts, antibiotics will be provided for at least two weeks.
2initial treatment phase
The participant will receive an intravenous (IV) infusion of either ravulizumab or a placebo. The medication is administered as a solution for infusion.
The purpose of this phase is to evaluate the initial response to the treatment in terms of reducing protein levels in urine.
3interim analysis
At Week 34, an interim analysis will be conducted to assess changes in protein levels in urine compared to the baseline.
This analysis helps determine the effectiveness of ravulizumab in reducing proteinuria.
4ongoing treatment and monitoring
The participant will continue to receive the IV infusion of ravulizumab or placebo over a period of 106 weeks.
Regular assessments will be conducted at Weeks 10, 26, 34, 50, and 106 to monitor changes in kidney function and protein levels in urine.
5final analysis
At the end of the study period, a final analysis will be performed to evaluate the overall effectiveness of ravulizumab in slowing the decline of kidney function.
The primary focus will be on the rate of decline in estimated glomerular filtration rate (eGFR) over the 106 weeks.
Who Can Join the Study?
Participant must be at least 18 years old at the time of signing the informed consent.
Must be taking a stable and maximum allowed or tolerated dose of RASI (a type of medication that includes ACEI and/or ARB) for at least 3 months before the study starts, with no planned changes during the study. Participants who cannot tolerate these medications may still join.
If taking SGLT2I, ERA, or MRA (types of medications), the dose must be stable and maximum allowed or tolerated for at least 3 months before the study starts, with no planned changes during the study.
Blood pressure must be controlled and less than 140/90 mmHg at the start of the study.
Must be vaccinated against meningococcal infection (a type of bacterial infection) from specific serogroups within 3 years before the study starts. If vaccinated less than 2 weeks before the study, must take preventive antibiotics for at least 2 weeks after vaccination.
Must have a documented diagnosis of IgAN (a kidney condition) confirmed by a kidney biopsy done any time before or during the study screening period.
Must have a UPCR (a measure of protein in urine) of at least 0.75 g/g or UP (urinary protein) of at least 1 g/day from the average of two 24-hour urine collections during the screening.
Must have an estimated GFR (a measure of kidney function) of at least 30 mL/min/1.73 m² at the start of the study, calculated by a specific method. For an exploratory group, the eGFR can be between 20-29 mL/min/1.73 m², with a kidney biopsy required within 6 months before or during the screening.
Must have hematuria, which means blood in the urine, as shown by a positive urine test or at least 5 red blood cells per high power field in urine sediment during or within 3 months of screening.
Must weigh at least 30 kg at the start of the study.
Can be male or female.
Must agree to follow specific guidance on contraception as outlined in the study protocol.
Must be capable of giving signed informed consent, which means understanding and agreeing to the study’s requirements and restrictions.
Who Cannot Join the Study?
Patients who have a history of severe allergic reactions to the study medication or similar medications.
Patients with other kidney diseases that are not related to Immunoglobulin A Nephropathy (IgAN).
Patients who have had a kidney transplant.
Patients who are currently receiving treatment with medications that could interfere with the study results.
Patients with serious infections or other medical conditions that could affect their participation in the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or attend study visits.
Ravulizumab is a medication being studied for its ability to help people with a kidney condition called Immunoglobulin A Nephropathy (IgAN). This condition can cause the kidneys to leak protein into the urine, which is not normal. The trial is looking at how well Ravulizumab can reduce this protein leakage and slow down the decline in kidney function.
Immunoglobulin A Nephropathy (IgAN) – This is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys, leading to inflammation that can affect the kidneys’ ability to filter waste from the blood. Over time, this buildup can cause the kidneys to become less effective at their job, potentially leading to chronic kidney damage. The disease often progresses slowly, and symptoms may not be noticeable in the early stages. As the condition advances, individuals may experience blood in the urine, protein in the urine, swelling in the hands and feet, and high blood pressure. The progression of IgAN can vary widely among individuals, with some experiencing only mild symptoms and others developing more severe kidney damage.
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