A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy
- Conditions
- IgA NephropathyMedDRA version: 20.0Level: PTClassification code: 10021263Term: IgA nephropathy Class: 100000004857Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-508690-92-00
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 498
Signed informed consent must be obtained prior to participation in the REP; participants should be able to communicate well with the Investigator, understand and comply with the requirements of the study., For CLNP023X2203, participants must have completed Part 1 or Part 2 of the trial. For other parent trials participants must have completed the entire parent trial duration defined by the respective protocol., 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 judgment, 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 stable dose of ACEi or ARB* as per KDIGO guidelines (KDIGO 2021). * Participants with allergies or intolerance to ACEi and ARB are eligible for the study but the Investigator should clearly document the reasons for not being on maximal ACEi/ARB dose in the source documents.
Participants who are screen or baseline failed in any of the iptacopan parent studies in IgAN or who prematurely withdrew from iptacopan parent studies in IgAN 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 iptacopan., Current (within 4 weeks prior to study treatment administration in the REP) acute kidney injury (AKI) defined by AKIN criteria., Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months., Participants treated with immunosuppressive or other immunomodulatory 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 90 days prior to first study drug administration. Rituximab requires 180 days wash out. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration., Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment or within 30 days whichever is longer, History of recurrent invasive infections caused by encapsulated organisms, such as Neisseria meningitidis, Streptococcus pneumoniae and Hemophilus influenzae.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the long-term safety and tolerability<br>of iptacopan in eligible participants.;Secondary Objective: The secondary objective is to characterize the clinical benefit (efficacy) of iptacopan in eligible participants receiving open-label iptacopan.;Primary end point(s): Safety and tolerability endpoints (including but not limited to AEs/SAEs, safety laboratory parameters, vital signs).
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Annualized total eGFR slope.;Secondary end point(s):Change from baseline in eGFR.;Secondary end point(s):Log transformed ratio to baseline in UPCR, UACR.