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 a Novartis-sponsored iptacopan parent study in IgAN - CLNP023A2002B

ovartis Pharma AG0 个研究点目标入组 498 人开始时间: 2024年3月26日最近更新: 2024年8月21日

研究概览

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•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.

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