The first step toward enrollment is to see if you may qualify for this study. Answer a few short questions online to see if you may be eligible.
Immunoglobulin A nephropathy (IgAN) is a serious condition characterized by a progressive loss of kidney function that leads to end-stage kidney disease (ESKD) in 24-53% of patients over 10 to 30 years1. If you have IgA Nephropathy, participation in this study may be right for you. Learn more about this study below and complete the pre-screener today.
The purpose of this clinical study is to determine how safe and effective an investigational medication is at treating IgA Nephropathy. If enrolled in the study, you may receive either the investigational medication or placebo as a subcutaneous injection every 2 weeks for approximately 2 years. Study procedures may include physical examinations, electrocardiograms (ECGs), laboratory tests, and vital signs. You do not have to pay for the investigational study drug or study procedures that are not part of your routine medical care. However, you may be responsible for paying for routine medical care that may be performed during the trial, some of which may be covered by your insurance.
18 years of age or older.
Diagnosed with a biopsy-confirmed IgA Nephropathy within the last 10 years.
On a stable dose of medications for IgA Nephropathy for at least 3 months.
Some symptoms of IgA Nephropathy may include2:
The first step toward enrollment is to see if you may qualify for this study. Answer a few short questions online to see if you may be eligible.
If you may be eligible and grant permission, a Study Team representative will call you within two business days to confirm your eligibility. If eligible, the final step is to visit a site near you. You will meet with a Study Doctor and/or Study Staff to complete your enrollment paperwork as well as answer any questions you may have about the study.
Participation will last approximately 2 years and 7 months. During the study, you will be asked to visit the study site between 13 and 57 times, depending on whether you choose to self-administer the investigational study drug or have it administered in-office. You will be required to complete electrocardiograms (ECGs), laboratory tests, 24-hour urine collections and physical examinations. Participation in this clinical trial is completely voluntary. You can leave at any time, and for any reason, without impact on your regular care.
The study is being sponsored by Novartis.
You have a 50:50 (1 in 2) chance of receiving the investigational medication.
You have a 50:50 (1 in 2) chance of receiving a placebo.
All participants will be monitored for adverse reactions to the investigational medication and attend regularly scheduled follow-up visits during the study per the protocol.
Taking part in a clinical study may or may not benefit you directly, but we may learn new things that could help advance IgAN research.
This study requires patients to be on a stable dose of either ACE inhibitors, ARBs for at least 3 months, and allows patients to also be on SGLT2 inhibitors, ERAs, and/or MRAs for at least 3 months. The study doctor will review any other medications you are currently taking and determine which medications can be continued, adjusted, or need to be discontinued prior to the study.
This is a Phase 3 clinical trial.
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Data you submit is handled according to our Privacy Policy and web site user agreements.