Status:
RECRUITING
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Primary IgA Nephropathy
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A23...
Detailed Description
This is an open-label, non-randomized, multicenter roll-over extension program (REP) to: * CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on efficacy, pharmacokinetic...
Eligibility Criteria
Inclusion Criteria:
-
For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment 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 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 ACEi or ARB* as per KDIGO guidelines.
- participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study
Exclusion Criteria:
- 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 LNP023.
- Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
- 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 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 and pneumococcus.
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 25 2032
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT04557462
Start Date
September 20 2021
End Date
October 25 2032
Last Update
February 23 2026
Active Locations (161)
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1
AZ Kidney Dise and Hypertension Ctr
Glendale, Arizona, United States, 85306
2
Kaiser Permanente
San Diego, California, United States, 92111
3
North America Research Institute
San Dimas, California, United States, 91773
4
University of Colorado Anschutz
Aurora, Colorado, United States, 80045