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 IgA

Phase 3

• Conditions: IgA kidney disease; IgAN; 10029149

• Registration Number: NL-OMON56438
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 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 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.
• All transplanted participants (any solid organ, or bone marrow
transplantation).
• History of recurrent invasive infections caused by encapsulated organisms,
such as meningococcus, pneumococcus, and H. influenzae.
• Major concurrent comorbidities including but not limited to severe
uncontrolled hypertension, other chronic kidney disease (with or without kidney
failure), advanced cardiac disease (e.g., NYHA class IV), severe pulmonary
disease (e.g., severe pulmonary hypertension (WHO class IV), or hepatic disease
(e.g. active hepatitis) that in the opinion of the Investigator precludes
participant's participation in the study.
• Any medical condition deemed likely to interfere with the participant*s
participation in the study.
• Active systemic bacterial, viral (including COVID-19) or fungal infection
within 14 days prior to study treatment administration.
• Presence of fever >= 38°C (100.4°F) within 7 days prior to study treatment
administration.
• History of Human Immunodeficiency Virus (HIV) infection (known history of HIV
or test positive for HIV antibody at Screening).
• Liver disease or liver injury as indicated by abnormal liver function tests
(LFT) at screening as defined below. ALT (SGPT), AST (SGOT), GGT, alkaline
phosphatase and serum bilirubin will be tested.
• Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3
× upper limit of normal (ULN)
• Serum bilirubin must not exceed 2 × ULN
Participants from CLNP023X2203 study or any other parent study participants if
required by local regulations will be additionally tested for HBsAg and HCV-RNA
and are not eligible if the results are positive.
• History of hypersensitivity to any of the study treatments or its excipients
or to drugs of similar chemical classes or any participant who discontinued
study treatment in the parent study due to a suspected treatment related AE.
• History of malignancy of any organ system (other than localized basal cell
carcinoma of the skin or in situ cervical canc

Study & Design

• Study Type: Interventional
• Study Design: Not specified