Efficacy and safety of LNP023 compared with rituximab in iMN
Research type
Research Study
Full title
A randomized, treatment open-label, dose-blinded parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy
IRAS ID
234906
Contact name
Durga Kanigicherla
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2019-001734-34
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
Idiopathic (primary) membranous nephropathy MN is a disease of the kidney that causes an increase in the amount of protein eliminated in the urine. The disease is caused by abnormalities in the ‘’alternative pathway of complement’’ – part of our immune system which provides protection against infections.
Most patients with MN have significant disease, with approximately 40% developing end stage renal disease (ESRD) within 10 years.
LNP023 is a medicine that blocks key steps in the alternative complement pathway, which may improve MN.
The purpose of the study is to find out if the drug LNP023 is safe and has beneficial effects in people who have membranous nephropathy (MN) compared with rituximab.
The main objective of this research is to see whether taking LNP023 or rituximab for 6 months results in lower urine protein levels and to compare these two treatments in patients with MN. This study will also provide information on the dose of LNP023 to be used in future clinical studies with subjects who have been diagnosed with MN.
The study will include patients at an increased risk of developing ESRD and have a lower rate of spontaneous remission.
Patients treated with LNP023, will take two capsules twice daily for 24 weeks. Patients treated with rituximab will receive an intravenous infusion on twice during the study.
During the study, patients will visit their doctor in hospital 14 times. This includes two long visits lasting approximately 10 hours each. All other visits will last about 4 hours. During the visits, patients will undergo assessments to monitor their condition. In total, each patient’s participation will last 1 year and 3 months.
The study will last for approximately 3 years with 5 patients enrolled across 5 sites in the UK.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0570
Date of REC Opinion
18 Sep 2019
REC opinion
Favourable Opinion