The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.
eGFR* ≥ 20 ml/min/1.73m2
Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.
participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
Single group
LNP023
DrugCapsule 200 mg (b.i.d.) taken orally twice a day
Number and percentage of participants with serious adverse event
Summary statistics on serious adverse events
Number and percentage of participants with adverse event
Summary statistics on adverse events
Number and percentage of participants with adverse events of special interest
Summary statistics on adverse events of special interest
Number and percentage of participants with abnormalities in vital signs
Summary statistics on abnormalities in vital sign parameters
Annualized total eGFR slope
Annualized rate of renal disease progression as measured by mean eGFR slope at post baseline visits
Change from baseline in eGFR
Average change from baseline in eGFR at post-baseline visits
Log transformed ratio to baseline in UPCR, UACR
Log transformed ratio to baseline in UPCR, UACR at post-baseline visits. The log transformation refers to the natural log (base on e)
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