A study to look at the effects and safety of a new medicine (iptacopan) in patients with IC-MPGN
Research type
Research Study
Full title
A multicentre, randomised, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN)
IRAS ID
1006341
Contact name
Pierre Zimmermann
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2022-002328-11
Clinicaltrials.gov Identifier
Research summary
IC-MPGN is a very rare, severe disorder of excessive activation of the alternative complement pathway (AP). AP is an important part of immune system in the body which provides protection against infections, however, an over-activated AP is believed to contribute to several kidney diseases, including IC-MPGN. Iptacopan blocks key steps in the AP that may improve IC-MPGN. This study will review the effectiveness and safety of a new potential medication; iptacopan compared to placebo (like a sugar pill, has no medical effects) in 68 participants ages 12-60 years of age with idiopathic IC-MPGN. The trial aims to assess reduction in protein in the urine and an improved estimated glomerular filtration rate (eGFR) which is a measure of how well your kidneys work in those participants receiving iptacopan vs placebo.
Participants will receive blinded treatment (neither doctor or participant will know what partcipant are taking unless in emergency) of either iptacopan or placebo for 6 months. Post 6 months all participants will receive iptacopan for an additional 6 months , followed by a safety follow up period. During the study participants will attend 12 visits at schedule timepoints during the course of the study, at these visits different assessments will occur to help review drug safety and effectiveness, for example blood sampling, vital sign checks, urine collection, patient questionnaires , ECGs , and ECHOs.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
23/WM/0134
Date of REC Opinion
14 Sep 2023
REC opinion
Further Information Favourable Opinion