A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

To join this study, you must have already finished one of two previous studies involving iptacopan (called CLNP023X2203 or CLNP023A2301) and have been taking the study drug.

Your kidney function, measured by something called eGFR, needs to be at a certain level (20 ml/min/1.73m2 or higher). The study doctor will need to agree that continuing to receive this treatment could be beneficial for you. You must also be up-to-date with certain vaccinations, including those for meningitis, pneumonia, and Haemophilus influenzae. Additionally, you should be receiving standard care for IgA Nephropathy, which usually involves specific blood pressure medications like ACE inhibitors or ARBs, unless you have a documented allergy to them.

There are also some reasons why you wouldn't be able to join. For example, if you dropped out of the previous studies early, or if you have certain other kidney problems not related to IgA Nephropathy. You also can't join if you have very sudden and rapid worsening of your kidney function, or if you've recently taken certain other strong immune-system-affecting medications.

If you join this study, you would continue to receive the medication iptacopan. You would have regular visits to the clinic so the study team can monitor your health, take blood and urine samples, and check your kidney function. These check-ups will happen every six months. The total length of your participation can vary, but generally, it could last up to three years, or until the medicine becomes widely available in your country, or if your doctor feels the treatment is no longer helping you. You can choose to stop participating at any time.