Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

Launched by NOVARTIS PHARMACEUTICALS · May 15, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called iptacopan to see how well it works over a long period for patients with conditions known as C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis. These are kidney diseases that can affect how well the kidneys filter blood. The trial is currently recruiting participants who have already completed a previous study involving iptacopan and are willing to continue treatment.

To be eligible, patients must have finished the treatment period of specific earlier studies and generally be in good health, without severe heart or lung diseases. Participants should not have any active infections or significant health issues that might make it unsafe to take the medication. Those who join can expect to receive iptacopan and will be monitored for its effectiveness, safety, and how well they tolerate the treatment. This study aims to gather important long-term data to help improve care for people with these kidney conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
• Exclusion Criteria:
• • Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study
• • Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening.
• • History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects
• • History of HIV or any other immunodeficiency disease
• • Other protocol-defined inclusion/exclusion criteria may apply