IgA Nephropathy (IgAN) is the most common type of kidney inflammation worldwide. The body creates antibodies against IgA, and together they form clumps (called immune complexes) that get stuck in the kidneys. These clumps trigger inflammation and scarring, which can damage the kidney over time. Some people with IgAN may not notice any symptoms, while others might see blood in their urine or develop kidney problems requiring dialysis and/or kidney transplantation.

The Verdant study is designed to evaluate how the investigational study drug* may work (also known as efficacy) and how safe it is for the use in adults living with IgAN. This study will evaluate the clinical study drug compared to a placebo. 

*The investigational study drug, ARGX-121, is not approved by any regulatory agency for use in IgAN as efficacy and safety have not been established

IgAN patients may be eligible to participate if they are:

• At least 18 years old
• Not pregnant, or actively trying to get pregnant
• Diagnosed with IgAN

Additional criteria to participate apply which the study doctor will discuss. 

If joining the study participation will be for up to 72 to 80 weeks (about 1.5 years). During this time, approximately 24 site visits may be required

During the study period usual medical care and medications for IgA nephropathy will continue, unless the study doctor tells you otherwise.

The study consists of 3 phases: 

Screening phase: within 4 weeks (approximately 1 month), extension may be permitted up to 8 weeks or 12 weeks (approximately 3 months).

Treatment phase: up to 52 weeks (approximately 12 months).

• During the first 24 weeks (about 5.5 months), either the investigational study drug or the placebo will be administered. There is a 66% chance of receiving the investigational study drug and a 33% chance of receiving placebo during this period.
• After the first 24 weeks, the investigational study drug will be administered for up to 28 weeks (about 6.5 months).
• The investigational study drug or placebo will be administered every 4 weeks as an injection through a needle under the skin (subcutaneously).

Follow up phase: up to 16 weeks (approximately 4 months) after the last dose