Recruiting
Phase 3

Iptacopan

Sponsor:

Novartis Pharmaceuticals

Code:

NCT04557462

Conditions

Primary IgA Nephropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LNP023

Study Details

Brief summary:

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.

Conditions

Primary IgA Nephropathy

Study ID

NCT04557462

Start date

Sep 20, 2021

Status verified date

Sep, 2026

Completion date

Dec 4, 2030

Anticipated

Primary completion date

Dec 4, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

\*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
  • 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.
  • All participants must be on supportive care regimen of ACEi or ARB\* as per KDIGO guidelines.

  • participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study

Exclusion Criteria:

  • 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.
  • Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out.
  • Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
  • History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.

Study Design

Enrollment

540 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LNP023

All participants are receiving 200 mg b.i.d

Interventions

LNP023

Capsule 200 mg (b.i.d.) taken orally twice a day

Primary outcome measure

  • Number and percentage of participants with serious adverse event [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Col Uni Med Center New York Presby

Recruiting

New York, New York, United States, 10032

Contacts

Anup Pradhan

arp2209@cumc.columbia.edu

Principal Investigator:

Pietro Canetta

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • Immunoglobulin A nephropathy
  • Primary IgA nephropathy
  • IgAN
  • chronic kidney disease
  • glomerulonephritis
  • complement alternative pathway
  • eGFR
  • UPCR
  • UACR
  • LNP023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.