A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy

Phase 1

• Conditions: IgA Nephropathy; MedDRA version: 20.0Level: PTClassification code 10021263Term: IgA nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-002200-40-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-24
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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 LNP023X2203, patients must have completed part 1 or part 2 of the trial. For other parent trials, patients must have completed the entire parent trial 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 judgement, the patient 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 patients must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines (KDIGO 2021).
* Patients 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 478
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

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 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.
-Patients 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. Participants
treated with endothelin (receptor) antagonists within 90 days prior to
first study drug administration.
-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, pneumococcus and H. influenzae.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified