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 nephropathySystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-002200-40-CZ
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 427
-For LNP023X2203, patients must have completed part 1 or part 2 of the trial. For LNP023A2301, patients must have completed the entire parent trial defined as the full 24 month double-blind 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 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.
* 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 405
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
-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 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.
-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
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the long-term safety and tolerability of iptacopan in eligible CLNP023X2203 or CLNP023A2301 participants receiving open-label iptacopan.;Secondary Objective: The secondary objective is to characterize the clinical benefit (efficacy) of iptacopan in eligible CLNP023X2203 and CLNP023A2301 participants receiving open-label iptacopan.;Primary end point(s): Safety and tolerability endpoints (including but not limited to adverse events/serious adverse events, safety laboratory parameters, vital signs).<br>;Timepoint(s) of evaluation of this end point: Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Annualized total eGFR slope<br>- Change from baseline in eGFR<br>- Log transformed ratio to baseline in UPCR, UACR;Timepoint(s) of evaluation of this end point: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months