* A multicentre extension study for Ipatcopan in adults with IgAN
Research type
Research Study
Full title
A multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301
IRAS ID
304138
Contact name
Edwin Wong
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Eudract number
2020-002200-40
Duration of Study in the UK
7 years, 0 months, 8 days
Research summary
IgA nephropathy (IgAN) is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) lodges in the kidneys. When antibodies lodge in the kidneys, local inflammation occurs that can cause the kidneys to leak blood and protein, and over time, may hamper the kidneys' ability to filter wastes from blood. Approximately 25% of IgAN patients develop proteinuria and hypertension. Many of these patients develop End Stage Renal Disease (ESRD) within 10 years.
There is no cure for IgAN. The goal of IgAN treatment is to prevent or delay ESRD. Treatment of IgAN has not changed significantly during the last three decades and effective, approved therapy is lacking. Guidelines recommend therapy based on angiotensin converting enzyme inhibitor (ACEis) or angiotensin receptor blocker (ARBs) with or without high dose steroids and cytotoxic agents, for blood pressure control and proteinuria reduction (KDIGO 2012). However, immunosuppressive agents (including steroids), have considerable side-effects and are only moderately effective in treating IgAN.
Iptacopan is a drug that blocks key steps in the “alternative complement pathway”, which is known to be activated in the kidney of most patients with IgAN, and as such may improve IgA nephropathy.
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy adult participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials.
The study will run approximately 7 years with 3 patients across 3 sites. This is an open-label, non-randomized, multicenter, rollover extension program (REP) to evaluate the long-term safety and tolerability of iptacopan in participants receiving iptacopan who have completed one of the Novartis-sponsored studies CLNP023X2203 or CLNP023A2301 and who, in the opinion of the Investigator, would benefit from treatment with iptacopan.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
22/WM/0196
Date of REC Opinion
19 Oct 2021
REC opinion
Favourable Opinion