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A clinical research study is now underway to study the safety and effectiveness of a study medication for adults with immunoglobulin A nephropathy, also known as IgAN or Berger’s disease. The I CAN Study is a phase 3 clinical research study evaluating ravulizumab, a medication that works differently than other currently approved IgAN treatments. This treatment is administered less frequently – every 8 weeks – which may be more convenient and support individuals with IgA nephropathy in maintaining adherence to their therapy.
If you or someone you love has been diagnosed with IgAN, please read on to learn more about the I CAN Study and why patient involvement in developing treatments for this serious and rare disease is so important.
About IgA Nephropathy
IgAN is a rare disease caused by abnormal activity of the immune system, affecting the kidneys’ filters, the glomeruli. A combination of genetic and environmental factors may contribute to the development of the disease.
Patients with IgAN create abnormal IgA proteins, which are part of the immune system. The body recognizes these abnormal proteins as foreign, which leads to an immune response that damages the kidneys over time, resulting in blood and protein leakage into urine.
IgAN is a lifelong disease, with 30%–40% of patients progressing to end-stage renal disease after 20 to 30 years of living with the condition.
How Is Ravulizumab Different?
Many treatments currently used to treat IgAN primarily focus on alleviating negative consequences of the disease rather than targeting its underlying cause. Ravulizumab, which is being evaluated in the I CAN Study, takes a different approach by aiming to block the inflammatory response triggered by abnormal IgA proteins. It does this by binding to the complement protein C5, a key part of the immune system involved in defending against bacteria. When C5 is activated, it splits to C5a and C5b-9, which are associated with kidney inflammation and damage. By binding to C5, ravulizumab prevents the release of these proteins, potentially reducing inflammation and slowing down the progression of kidney damage.
Patient Involvement Is Key
People living with IgAN may be apprehensive about participating in a clinical research study. However, there are many good reasons to consider getting involved in the I CAN Study:
- Because of its unique way in acting on the body, ravulizumab targets one of the underlying mechanisms of IgAN, potentially resolving negative consequences and the method of disease progression
- Discoveries made in clinical research studies could result in treatment breakthroughs that may be more effective than current methods, which could benefit future generations of patients
- Participants of all backgrounds with IgAN are needed. Studies that are diverse in age, gender, and race produce much more valuable and useful data
There is also an open-label ravilizumab access period at the end of the study that will allow all patients (including those who received the placebo) to receive ravulizumab for 2 more years.
You may qualify for this clinical research study if you:
- Have a confirmed diagnosis of IgAN based on kidney biopsy
- Are at least 18 years or older
- Have been treated with stable doses of blood pressure medications for your IgAN for more than three months before screening
There are certain considerations to participation in the I CAN Study, including the following:
- A biopsy confirming IgAN diagnosis is required to enroll in this study. This is an invasive procedure that participants may not be comfortable undergoing. If a biopsy has not been completed, a participant will have the opportunity to have a biopsy done during the screening period
- Contraceptive use is required during this study, and participants looking to start a family will be excluded from the trial
- Participants may be placed on a placebo treatment, which looks just like the study medication, when being randomized during the initial study period
- Ravulizumab is administered via IV infusion, which means that participants will not be able to administer this drug in an outpatient setting
- Participants must be vaccinated against N. meningitidis (meningococcal infection), which may be challenging for some participants
If you or someone who you know is living with IgAN, participating in this study could allow them access to a new investigational option for managing their disease.
