A Phase 3 interventional study of LNP023 in Primary IgA Nephropathy, sponsored by Novartis Pharmaceuticals. Recruiting at 161 sites in 36 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
This is an open-label, non-randomized, multicenter roll-over extension program (REP) to:
Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until:
254 studies on the registry are indexed under Glomerulonephritis, IGA; 100 are open to participants now.
This study's planned enrollment of 540 is above the median of 70 across 206 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
eGFR* ≥ 20 ml/min/1.73m2
*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
All participants must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines.
Exclusion Criteria:
All participants are receiving 200 mg b.i.d
Drug: LNP023
Capsule 200 mg (b.i.d.) taken orally twice a day
Also known as: iptacopan
Number and percentage of participants with serious adverse event
Summary statistics on serious adverse events
Time frame: Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse event
Summary statistics on adverse events
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse events of special interest
Summary statistics on adverse events of special interest
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment
Number and percentage of participants with abnormalities in vital signs
Summary statistics on abnormalities in vital sign parameters
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in ECG
Summary statistics in abnormalities in ECG parameters
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Summary statistics on abnormalities in clinical laboratory evaluations
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Annualized total eGFR slope
Annualized rate of renal disease progression as measured by mean eGFR slope at post baseline visits
Time frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Change from baseline in eGFR
Average change from baseline in eGFR at post-baseline visits
Time frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
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)
Time frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Showing the first 100 of 161 sites across 36 countries.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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