Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
I CAN Clinical Study for Patients with IgAN
I CAN
Brief Description
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
Trial Physician / Study Coordinator
Veronica Almanza
Email PhoneSite Name
Dallas Renal Group
Sponsor
Alexion, Astra Zeneca Rare Disease
Study Drug
Ravulizumab
Estimated enrollment
470
Estimated end date
07/2027
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
I CAN Clinical Study for Patients with IgAN
I CAN
Brief Description
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
Trial is for people with
• 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 your 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 your urine
Study Goal
Through the I CAN study, we aim to prioritize research to aid the global IgAN community.
What is involved for the Patient?
Screening: Lasts approximately six weeks and includes two visits. The study team will review your medical history and perform tests to see if you qualify for the study. If you qualify, your study doctor will make sure you are receiving renin angiotensin system inhibitor (RASi) therapy (a type of antihypertensive therapy) for at least three months before study treatment may begin. You will continue taking RASi as background therapy throughout the study.
Study Treatment: Lasts approximately two years and includes 15 visits. During this period, you are randomly assigned to receive either the study medication or a placebo, which looks just like the study medication but contains no active ingredients. You should continue your stable treatment that is consistent for your IgAN care. The study team will perform procedures and assessments during study visits to check on your health.
Ravulizumab Access: This period is optional, lasts approximately two years, and includes 14 visits. If you decide to enter this optional period, you will receive the study medication for approximately two years after the study treatment period.
About the drug or intervention
The study medication is called ravulizumab (ALXN1210). It is being used in the study for research purposes only. While ravulizumab has not been approved by country-specific regulatory health authorities to be used in treating IgAN, it has been approved by various regulatory health authorities for use in treatment of other diseases.
IgAN occurs when immunoglobulin A (IgA), an antibody normally produced by the immune system to fight bacteria and viruses, builds up in the kidneys and causes inflammation and damage, potentially leading to kidney failure.
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 through the complement protein C5, the study medication may 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.