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Currently Enrolling
Interventional

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

Currently Enrolling
Interventional

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.

Dallas, TX (Dallas Renal Group)
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

Clinical studies are any studies that involve people. There are two main types: observational and interventional. In an observational trial, researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease. In an interventional trial, participants receive specific interventions, which can include new treatments or behavorial changes (e.g., diet changes). To learn more about clinical research, please visit the NephCure website.