A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
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 Study CLNP023X2203 or CLNP023A2301
2 other identifiers
interventional
540
35 countries
160
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 CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2021
Longer than P75 for phase_3
160 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedStudy Start
First participant enrolled
September 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 4, 2030
May 6, 2026
May 1, 2026
9.2 years
September 15, 2020
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number and percentage of participants with serious adverse event
Summary statistics on serious adverse events
Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse event
Summary statistics on adverse events
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse events of special interest
Summary statistics on adverse events of special interest
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment
Number and percentage of participants with abnormalities in vital signs
Summary statistics on abnormalities in vital sign parameters
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in ECG
Summary statistics in abnormalities in ECG parameters
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Summary statistics on abnormalities in clinical laboratory evaluations
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Secondary Outcomes (3)
Annualized total eGFR slope
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Change from baseline in eGFR
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Log transformed ratio to baseline in UPCR, UACR
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Study Arms (1)
LNP023
EXPERIMENTALAll participants are receiving 200 mg b.i.d
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (161)
AZ Kidney Dise and Hypertension Ctr
Glendale, Arizona, 85306, United States
Kaiser Permanente
San Diego, California, 92111, United States
North America Research Institute
San Dimas, California, 91773, United States
University of Colorado Anschutz
Aurora, Colorado, 80045, United States
Nephrology Associates PA
Newark, Delaware, 19713, United States
CaRe Research
Chubbuck, Idaho, 83202, United States
Nep Assoc of Northern Illinois
Hinsdale, Illinois, 60521, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, 02115, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Clin Rsrch Consult a JCCT Company
Kansas City, Missouri, 64111, United States
DaVita Clinical Research
Las Vegas, Nevada, 89146, United States
New Jersey Kidney Care
Jersey City, New Jersey, 07305, United States
Col Uni Med Center New York Presby
New York, New York, 10032, United States
Dallas Renal Group
Dallas, Texas, 75230, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
Novartis Investigative Site
Córdoba, Córdoba Province, 5000, Argentina
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Córdoba, Córdoba Province, X5016KEH, Argentina
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CABA, C1181ACH, Argentina
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CABA, C1426ABP, Argentina
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Santa Fe, S3000EPV, Argentina
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Woolloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5000, Australia
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Parkville, Victoria, 3065, Australia
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Roeselare, West-Vlaanderen, 8800, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Belo Horizonte, Minas Gerais, 30150-221, Brazil
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Curitiba, Paraná, 80440-020, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
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São Paulo, São Paulo, 04038-002, Brazil
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São Paulo, São Paulo, 05403 000, Brazil
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Sao Jose Rio Preto, 15090 000, Brazil
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Oshawa, Ontario, L1G 2B9, Canada
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Temuco, 4781151, Chile
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Beijing, Beijing Municipality, 100013, China
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Beijing, Beijing Municipality, 102218, China
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Guangzhou, Guangdong, 510030, China
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Luoyang, Henan, 471003, China
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Zhengzhou, Henan, 450003, China
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Changsha, Hunan, 410011, China
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Changchun, Jilin, 130041, China
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Yinchuan, Ningxia, 750004, China
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Ürümqi, Xinjiang, 830001, China
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Ningbo, Zhejiang, 315016, China
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Wenzhou, Zhejiang, 325000, China
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Beijing, 100034, China
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Guangzhou, 510080, China
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Ningbo, 315010, China
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Qingdao, 266000, China
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Shenzhen, 518036, China
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Medellín, Antioquia, 050001, Colombia
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Barranquilla, Atlántico, 080020, Colombia
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Prague, 128 08, Czechia
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Aalborg, 9000, Denmark
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Aarhus N, 8200, Denmark
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Copenhagen, DK-2100, Denmark
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Odense C, 5000, Denmark
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Marseille, 13005, France
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Montpellier, 34295, France
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Paris, 75015, France
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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Petah Tikva, 4941492, Israel
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Bologna, BO, 40138, Italy
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Kasugai, Aichi-ken, 486-8510, Japan
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Toyoake, Aichi-ken, 4701192, Japan
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Toyota, Aichi-ken, 471-8513, Japan
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Sapporo, Hokkaido, 0068555, Japan
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Sapporo, Hokkaido, 0608604, Japan
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Kawasaki, Kanagawa, 213-8587, Japan
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Yokohama, Kanagawa, 224-8503, Japan
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Yokohama, Kanagawa, 236-0004, Japan
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Kyoto, Kyoto, 605-0981, Japan
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Niigata, 9518520, Japan
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Kuala Lumpur, 59100, Malaysia
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Bergen, NO-5021, Norway
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Saint Petersburg, 197110, Russia
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Košice, 040 11, Slovakia
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Maribor, Slovenia, 2000, Slovenia
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Ljubljana, 1000, Slovenia
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Bloemfontein, Free State, 9301, South Africa
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Busan, 47392, South Korea
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Stockholm, 141 86, Sweden
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Taichung, 40447, Taiwan
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Taipei, 10002, Taiwan
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Taoyuan, 33305, Taiwan
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Bangkok, 10330, Thailand
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Salford, M6 8HD, United Kingdom
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Ho Chi Minh City, VNM, 700000, Vietnam
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 15, 2020
First Posted
September 21, 2020
Study Start
September 20, 2021
Primary Completion (Estimated)
December 4, 2030
Study Completion (Estimated)
December 4, 2030
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.