Brief Description of Trial
I CAN is a Phase 3, double-blind, randomized, placebo-controlled study to evaluate the safety and effectiveness of ravulizumab (ALXN1210) in adults with immunoglobulin A nephropathy (IgAN).
Who is Eligible
Eligible participants must (at minimum):
- Be at least 18 years of age
- Have a diagnosis of IgAN based on kidney biopsy
- Have been treated with stable doses of blood pressure medications for their IgAN for more than three months before screening
- Not have a history of kidney transplant or plan to undergo a transplant during the treatment period
- Have protein in their urine
Study Goals
- The purpose of the I CAN study is to evaluate the safety and effectiveness of ravulizumab compared with placebo to potentially help manage symptoms in adults who have IgAN.
About the drug
- The study medication, ravulizumab is administered as intravenous (IV) infusions every eight weeks.
- The study medication binds to the complement protein C5. The complement system uses proteins in the immune system to defend the body against viruses and bacteria that may cause sickness.
- Through binding to the complement protein C5, the study medication may be able to stop C5 from forming the proteins C5a and C5b-9, which can cause kidney inflammation and damage.
- The study medication has the potential to provide anti-inflammatory effects, possibly halting progression of kidney damage.
What’s involved for the patient
- Participants will be randomly assigned to receive either the study medication or a placebo, which looks just like the study medication but contains no active ingredients.
- For every one participant who receives the study medication, one participant will receive the placebo.
- After about 2 years, all participants will have the opportunity to receive the study medication during the ravulizumab access period.
Visit www.ICANClinicalStudy.com to learn more and find out if you’re eligible.
Learn More Here
