Primary IgA NephropathyPhase 3NCT04557462

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 Phase 3 study testing LNP023 in people with Primary IgA Nephropathy, run by Novartis Pharmaceuticals at 161 sites in 36 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Primary IgA Nephropathy
What is being tested?: LNP023
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 540 participants
Where: 161 sitesin 36 countries
Study dates: 20 Sep 2021to 4 Dec 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

161 sites in 36 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

Country

City, postcode or hospital

Sites recruiting now only

161 sites in 36 countries

China20 sites

Novartis Investigative Site
Beijing, Beijing Municipality, 100013
Active, not recruiting
Novartis Investigative Site
Beijing, Beijing Municipality, 102218
Active, not recruiting
Novartis Investigative Site
Beijing, 100034
Active, not recruiting
Novartis Investigative Site
Changchun, Jilin, 130041
Active, not recruiting
Novartis Investigative Site
Changsha, Hunan, 410011
Active, not recruiting
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Active, not recruiting
Novartis Investigative Site
Guangzhou, 510080
Active, not recruiting
Novartis Investigative Site
Luoyang, Henan, 471003
Completed
Novartis Investigative Site
Ningbo, Zhejiang, 315016
Active, not recruiting
Novartis Investigative Site
Ningbo, 315010
Active, not recruiting
Novartis Investigative Site
Qingdao, 266000
Active, not recruiting
Novartis Investigative Site
Shanghai, 200025
Active, not recruiting
Novartis Investigative Site
Shanghai, 200040
Active, not recruiting
Novartis Investigative Site
Shenzhen, 518036
Active, not recruiting
Novartis Investigative Site
Taiyuan, Shanxi, 030001
Active, not recruiting
Novartis Investigative Site
Ürümqi, Xinjiang, 830001
Active, not recruiting
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
Active, not recruiting
Novartis Investigative Site
Xian, Shanxi, 710061
Active, not recruiting
Novartis Investigative Site
Yinchuan, Ningxia, 750004
Active, not recruiting
Novartis Investigative Site
Zhengzhou, Henan, 450003
Active, not recruiting

Other trials in China

Japan18 sites

Novartis Investigative Site
Chiba, 2608712
Active, not recruiting
Novartis Investigative Site
Kasugai, Aichi-ken, 4868510
Active, not recruiting
Novartis Investigative Site
Kawasaki, Kanagawa, 2138587
Active, not recruiting
Novartis Investigative Site
Kyoto, Kyoto, 6050981
Active, not recruiting
Novartis Investigative Site
Matsumoto, Nagano, 3908621
Active, not recruiting
Novartis Investigative Site
Niigata, 9518520
Active, not recruiting
Novartis Investigative Site
Okayama, 7008558
Active, not recruiting
Novartis Investigative Site
Ōmihachiman, Shiga, 5230082
Active, not recruiting
Novartis Investigative Site
Osaka, Osaka, 5340021
Active, not recruiting
Novartis Investigative Site
Osaka, 5300012
Active, not recruiting
Novartis Investigative Site
Osaka, 5308480
Active, not recruiting
Novartis Investigative Site
Sapporo, Hokkaido, 0068555
Active, not recruiting
Novartis Investigative Site
Sapporo, Hokkaido, 0608604
Completed
Novartis Investigative Site
Sendai, Miyagi, 9813205
Withdrawn
Novartis Investigative Site
Toyoake, Aichi-ken, 4701192
Active, not recruiting
Novartis Investigative Site
Toyota, Aichi-ken, 4718513
Active, not recruiting
Novartis Investigative Site
Yokohama, Kanagawa, 2248503
Active, not recruiting
Novartis Investigative Site
Yokohama, Kanagawa, 2360004
Active, not recruiting

Other trials in Japan

United States16 sites, 1 recruiting

University of Colorado Anschutz
Aurora, Colorado, 80045
Active, not recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Active, not recruiting
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, 02115
Completed
CaRe Research
Chubbuck, Idaho, 83202
Active, not recruiting
Dallas Renal Group
Dallas, Texas, 75230
Active, not recruiting
AZ Kidney Dise and Hypertension Ctr
Glendale, Arizona, 85306
Active, not recruiting
Nep Assoc of Northern Illinois
Hinsdale, Illinois, 60521
Active, not recruiting
Prolato Clinical Research Center
Houston, Texas, 77054
Withdrawn
New Jersey Kidney Care
Jersey City, New Jersey, 07305
Active, not recruiting
Clin Rsrch Consult a JCCT Company
Kansas City, Missouri, 64112
Completed
DaVita Clinical Research
Las Vegas, Nevada, 89146
Active, not recruiting
Col Uni Med Center New York Presby
New York, New York, 10032
Anup Pradhan, arp2209@cumc.columbia.edu
Pietro Canetta
Recruiting
Nephrology Associates PA
Newark, Delaware, 19713
Withdrawn
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Active, not recruiting
Kaiser Permanente
San Diego, California, 92111
Active, not recruiting
North America Research Institute
San Dimas, California, 91773
Active, not recruiting

Other trials in United States

Germany12 sites

Novartis Investigative Site
Aachen, 52074
Active, not recruiting
Novartis Investigative Site
Berlin, 13353
Active, not recruiting
Novartis Investigative Site
Essen, 45147
Active, not recruiting
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Active, not recruiting
Novartis Investigative Site
Hanover, 30625
Active, not recruiting
Novartis Investigative Site
Heidelberg, 69120
Withdrawn
Novartis Investigative Site
Kiel, 24105
Active, not recruiting
Novartis Investigative Site
Magdeburg, 39120
Active, not recruiting
Novartis Investigative Site
Mainz, 55131
Active, not recruiting
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, 70376
Active, not recruiting
Novartis Investigative Site
Tübingen, 72076
Active, not recruiting
Novartis Investigative Site
Ulm, 89081
Active, not recruiting

Other trials in Germany

South Korea11 sites

Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Active, not recruiting
Novartis Investigative Site
Busan, 47392
Active, not recruiting
Novartis Investigative Site
Cheongju-si, North Chungcheong, 28644
Active, not recruiting
Novartis Investigative Site
Seoul, Korea, 02841
Completed
Novartis Investigative Site
Seoul, Korea, 03312
Active, not recruiting
Novartis Investigative Site
Seoul, Seoul, 03080
Active, not recruiting
Novartis Investigative Site
Seoul, 03722
Active, not recruiting
Novartis Investigative Site
Seoul, 05278
Active, not recruiting
Novartis Investigative Site
Seoul, 06591
Active, not recruiting
Novartis Investigative Site
Seoul, 06973
Active, not recruiting
Novartis Investigative Site
Taegu, 41944
Active, not recruiting

Other trials in South Korea

Taiwan7 sites

Novartis Investigative Site
Kaohsiung City, 833
Active, not recruiting
Novartis Investigative Site
New Taipei City, 22060
Active, not recruiting
Novartis Investigative Site
New Taipei City, 23561
Active, not recruiting
Novartis Investigative Site
Taichung, 40447
Active, not recruiting
Novartis Investigative Site
Taichung, 407219
Completed
Novartis Investigative Site
Taipei, 10002
Active, not recruiting
Novartis Investigative Site
Taoyuan, 33305
Active, not recruiting

Other trials in Taiwan

Turkey (Türkiye)7 sites

Novartis Investigative Site
Ankara, Yenimahalle, 06500
Active, not recruiting
Novartis Investigative Site
Antalya, Konyaalti, 07070
Completed
Novartis Investigative Site
Istanbul, Fatih, 34098
Active, not recruiting
Novartis Investigative Site
Istanbul, Sariyer, 34396
Active, not recruiting
Novartis Investigative Site
Kayseri, Melikgazi, 38039
Active, not recruiting
Novartis Investigative Site
Köseköy, Kocaeli, 41380
Active, not recruiting
Novartis Investigative Site
Mersin, Yenisehir, 33110
Active, not recruiting

Other trials in Turkey (Türkiye)

Brazil6 sites

Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-221
Active, not recruiting
Novartis Investigative Site
Curitiba, Paraná, 80440-020
Active, not recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-074
Active, not recruiting
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15090 000
Active, not recruiting
Novartis Investigative Site
São Paulo, São Paulo, 04038-002
Active, not recruiting
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
Active, not recruiting

Other trials in Brazil

Argentina5 sites

Novartis Investigative Site
CABA, C1181ACH
Active, not recruiting
Novartis Investigative Site
CABA, C1426ABP
Active, not recruiting
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KEH
Active, not recruiting
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KET
Active, not recruiting
Novartis Investigative Site
Santa Fe, S3000EPV
Active, not recruiting

Other trials in Argentina

United Kingdom5 sites

Novartis Investigative Site
Cambridge, CB2 0QQ
Completed
Novartis Investigative Site
Leicester, LE5 4PW
Active, not recruiting
Novartis Investigative Site
London, SE5 9RS
Active, not recruiting
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Active, not recruiting
Novartis Investigative Site
Salford, M6 8HD
Active, not recruiting

Other trials in United Kingdom

Denmark4 sites

Novartis Investigative Site
Aalborg, 9000
Active, not recruiting
Novartis Investigative Site
Aarhus N, 8200
Active, not recruiting
Novartis Investigative Site
Copenhagen, 2100
Active, not recruiting
Novartis Investigative Site
Odense C, 5000
Active, not recruiting

Other trials in Denmark

India4 sites

Novartis Investigative Site
Bangalore, Karnataka, 560004
Active, not recruiting
Novartis Investigative Site
Hyderabad, Telangana, 500082
Active, not recruiting
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110017
Active, not recruiting
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110029
Active, not recruiting

Other trials in India

Australia3 sites

Novartis Investigative Site
Adelaide, South Australia, 5000
Active, not recruiting
Novartis Investigative Site
Parkville, Victoria, 3065
Active, not recruiting
Novartis Investigative Site
Woolloongabba, Queensland, 4102
Active, not recruiting

Other trials in Australia

Belgium3 sites

Novartis Investigative Site
Edegem, 2650
Active, not recruiting
Novartis Investigative Site
Leuven, 3000
Active, not recruiting
Novartis Investigative Site
Roeselare, West Vlaanderen, 8800
Active, not recruiting

Other trials in Belgium

France3 sites

Novartis Investigative Site
Marseille, 13005
Active, not recruiting
Novartis Investigative Site
Montpellier, 34295
Active, not recruiting
Novartis Investigative Site
Paris, 75015
Active, not recruiting

Other trials in France

Israel3 sites

Novartis Investigative Site
Ashkelon, 7830604
Active, not recruiting
Novartis Investigative Site
Jerusalem, 9112001
Active, not recruiting
Novartis Investigative Site
Petah Tikva, 4941492
Active, not recruiting

Other trials in Israel

Spain3 sites

Novartis Investigative Site
Barcelona, 08036
Active, not recruiting
Novartis Investigative Site
Pamplona, Navarre, 31008
Active, not recruiting
Novartis Investigative Site
Salamanca, 37007
Active, not recruiting

Other trials in Spain

Thailand3 sites

Novartis Investigative Site
Bangkok, 10330
Active, not recruiting
Novartis Investigative Site
Bangkok, 10400
Active, not recruiting
Novartis Investigative Site
Bangkok, 10700
Active, not recruiting

Other trials in Thailand

Colombia2 sites

Novartis Investigative Site
Barranquilla, Atlántico, 080020
Active, not recruiting
Novartis Investigative Site
Medellín, Antioquia, 050001
Active, not recruiting

Other trials in Colombia

Hungary2 sites

Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Active, not recruiting
Novartis Investigative Site
Pécs, Baranya, 7623
Active, not recruiting

Other trials in Hungary

Italy2 sites

Novartis Investigative Site
Bologna, BO, 40138
Active, not recruiting
Novartis Investigative Site
Naples, 80131
Active, not recruiting

Other trials in Italy

Malaysia2 sites

Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
Active, not recruiting
Novartis Investigative Site
Kuala Lumpur, 59100
Active, not recruiting

Other trials in Malaysia

Mexico2 sites

Novartis Investigative Site
Benito Juárez, Mexico City, 03100
Active, not recruiting
Novartis Investigative Site
Querétaro, 76000
Active, not recruiting

Other trials in Mexico

Norway2 sites

Novartis Investigative Site
Bergen, NO-5021
Active, not recruiting
Novartis Investigative Site
Nordbyhagen, Oslo, 1478
Active, not recruiting

Other trials in Norway

Russia2 sites

Novartis Investigative Site
Rostov-on-Don, 344022
Active, not recruiting
Novartis Investigative Site
Saint Petersburg, 197110
Active, not recruiting

Other trials in Russia

Singapore2 sites

Novartis Investigative Site
Singapore, 119074
Active, not recruiting
Novartis Investigative Site
Singapore, 169608
Active, not recruiting

Other trials in Singapore

Slovenia2 sites

Novartis Investigative Site
Ljubljana, 1000
Active, not recruiting
Novartis Investigative Site
Maribor, Slovenia, 2000
Withdrawn

Other trials in Slovenia

Vietnam2 sites

Novartis Investigative Site
Ho Chi Minh City, VNM, 700000
Active, not recruiting
Novartis Investigative Site
Ho Chi Minh City, 700000
Active, not recruiting

Other trials in Vietnam

Canada1 site

Novartis Investigative Site
Oshawa, Ontario, L1G 2B9
Withdrawn

Other trials in Canada

Chile1 site

Novartis Investigative Site
Temuco, 4781151
Active, not recruiting

Other trials in Chile

Czechia1 site

Novartis Investigative Site
Prague, 128 08
Active, not recruiting

Other trials in Czechia

Hong Kong1 site

Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Active, not recruiting

Other trials in Hong Kong

Netherlands1 site

Novartis Investigative Site
Groningen, Provincie Groningen, 9713 GZ
Active, not recruiting

Other trials in Netherlands

Slovakia1 site

Novartis Investigative Site
Košice, 040 11
Active, not recruiting

Other trials in Slovakia

South Africa1 site

Novartis Investigative Site
Bloemfontein, Free State, 9301
Active, not recruiting

Other trials in South Africa

Sweden1 site

Novartis Investigative Site
Stockholm, 141 86
Active, not recruiting

Other trials in Sweden

About this study

Official title: 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

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.

Read the 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, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and
CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN.

Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until:

3 years from LPFV of this study CLNP023A2002B, or
the participant no longer derives benefit from iptacopan according to the Investigator, or
the benefit-risk profile of the product in IgAN is no longer positive, or
initiation of maintenance hemodialysis, kidney transplantation or eGFR < 15 mL/min/1.73m2 , or
the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or
if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner

Conditions: Primary IgA Nephropathy
Being tested: LNP023
Keywords: Immunoglobulin A nephropathy, Primary IgA nephropathy, IgAN, chronic kidney disease, glomerulonephritis, complement alternative pathway, eGFR, UPCR, UACR, LNP023
Medical subject headings: Glomerulonephritis, IGA, Renal Insufficiency, Chronic, Glomerulonephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LNP023Drug
Also called iptacopan
Capsule 200 mg (b.i.d.) taken orally twice a day

Study groups in NCT04557462
Study group	Role	What they receive
LNP023	Experimental	All participants are receiving 200 mg b.i.d Receives: Drug: LNP023

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and percentage of participants with serious adverse event
Summary statistics on serious adverse events
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Annualized rate of renal disease progression as measured by mean eGFR slope at post baseline visits
Measured: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Change from baseline in eGFR
Average change from baseline in eGFR at post-baseline visits
Measured: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Log transformed ratio to baseline in UPCR, UACR
Log transformed ratio to baseline in UPCR, UACR at post-baseline visits. The log transformation refers to the natural log (base on e)
Measured: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 20214 Dec 2030

First posted21 Sep 2020
Study start20 Sep 2021
Primary completion4 Dec 2030 (estimated)
Study completion4 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary IgA NephropathyStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 540 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04557462
Sponsor's protocol ID: CLNP023A2002B
Other IDs: 2020-002200-40
Status last verified: Sep 2026
First submitted: 15 Sep 2020
Last updated: 5 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.
Expanded access: Available

Publications

Rovin BH, Trimarchi H, Maes B, Perkovic V, Kashihara N, Zhang H, Barratt J, Cheng H, Lee H, Lee SH, Lim SK, Raju SB, Satirapoj B, Seyahi N, Tian YC, Wu CH, Xiong ZY, Xue H, Yee SY, Petrovic-Bulatovic K, Attari Z, Butylin D, Jacinto-Sanders S, Pletscher M, Magirr A, Renfurm R, Hach T, Rizk DV. Long-term efficacy and safety for the complement factor B inhibitor iptacopan in IgA nephropathy. Kidney Int. 2026 Oct 22:S0085-2538(26)00826-4. doi: 10.1016/j.kint.2026.09.017. Online ahead of print.
PubMed 42909451

Interested in taking part?

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruitingPhase 4
Efficacy and Safety of Obinutuzumab Beta in Primary IgA Nephropathy With Active Pathological Lesions
Primary IgA Nephropathy
Not yet recruitingPhase 1
IBI3034 Study in Healthy Adults and Patients With Primary IgA Nephropathy
IgA Nephropathy (IgAN)
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
Not yet recruitingPhase 2
A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
Immunoglobulin A Nephropathy (IgAN)

All Primary IgA Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04557462
Acronym / sponsor ID: CLNP023A2002B
Conditions: Primary IgA Nephropathy
Keywords: Immunoglobulin A nephropathy, Primary IgA nephropathy, IgAN, chronic kidney disease, glomerulonephritis, complement alternative pathway, eGFR, UPCR
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 540 participants (estimated)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 20 Sep 2021 (actual)
Primary completion: 4 Dec 2030 (estimated)
Study completion: 4 Dec 2030 (estimated)
First posted: 21 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and
CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN.

3 years from LPFV of this study CLNP023A2002B, or
the participant no longer derives benefit from iptacopan according to the Investigator, or
the benefit-risk profile of the product in IgAN is no longer positive, or
initiation of maintenance hemodialysis, kidney transplantation or eGFR < 15 mL/min/1.73m2 , or
the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or
if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LNP023	Experimental	Drug: LNP023All participants are receiving 200 mg b.i.d

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LNP023Also: iptacopanCapsule 200 mg (b.i.d.) taken orally twice a day	Drug	LNP023

Primary outcome

Number and percentage of participants with serious adverse event
Time frame: Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on serious adverse events
Number and percentage of participants with adverse event
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on adverse events
Number and percentage of participants with adverse events of special interest
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment
Summary statistics on adverse events of special interest
Number and percentage of participants with abnormalities in vital signs
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on abnormalities in vital sign parameters
Number and percentage of participants with abnormalities in ECG
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics in abnormalities in ECG parameters
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on abnormalities in clinical laboratory evaluations

3 secondary outcomes

Annualized total eGFR slope
Time frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Change from baseline in eGFR
Time frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Log transformed ratio to baseline in UPCR, UACR
Time frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Derived from this study: PubMed 42909451Rovin BH, Trimarchi H, Maes B, Perkovic V, Kashihara N, Zhang H, Barratt J, Cheng H, Lee H, Lee SH, Lim SK, Raju SB, Satirapoj B, Seyahi N, Tian YC, Wu CH, Xiong ZY, Xue H, Yee SY, Petrovic-Bulatovic K, Attari Z, Butylin D, Jacinto-Sanders S, Pletscher M, Magirr A, Renfurm R, Hach T, Rizk DV. Long-term efficacy and safety for the complement factor B inhibitor iptacopan in IgA nephropathy. Kidney Int. 2026 Oct 22:S0085-2538(26)00826-4. doi: 10.1016/j.kint.2026.09.017. Online ahead of print.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

161 sites in 36 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LNP023 in people with Primary IgA Nephropathy, run by Novartis Pharmaceuticals at 161 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in China, Japan, United States, Germany, South Korea and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and percentage of participants with serious adverse event (time frame: Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04557462, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.