AzTrials
AzTrials

IgA NephropathyPhase 3ALIGNNCT04573478

Atrasentan in Patients With IgA Nephropathy

A Phase 3 study testing Atrasentan and Zigakibart in people with IgA Nephropathy and Immunoglobulin A Nephropathy, run by Novartis Pharmaceuticals at 135 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Nephropathy, Immunoglobulin A Nephropathy
What is being tested?
Atrasentan and Zigakibart
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
135 sitesin 20 countries
Study dates
11 Dec 2020to 14 Apr 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Double-Blind period:
  • Biopsy-proven IgA nephropathy.
  • Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. Exceptions from this requirement will be made for subjects who are unable to tolerate RAS inhibitor therapy.
  • Total urine protein ≥1 g/day as measured via 24-hour urine collection by central laboratory at Screening.
  • eGFR of at least 30 mL/min/1.73 m^2 at Screening based on the CKD-EPI equation.
  • Willing and able to provide informed consent and comply with all study requirements.
Show all 18Show fewer
  • SGLT2i Stable Stratum Only - Receiving a stable dose of an SGLT2i (per Investigator choice) in addition to a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to Screening.
  • All fertile men and WOCBP who engage in heterosexual intercourse must be willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the study and for 1 month afterward. In WOCBP, use of contraceptive agents must have been started at least 1 month prior to Baseline.
  • Open-Label Period:
  • Willing and able to provide informed consent and comply with all OL extension study visits and study procedures.
  • Completed treatment through Week 132 and completed the Week 136 visit.
  • All fertile men and WOCBP who engage in heterosexual intercourse must be willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the study and for 1 month afterward. In WOCBP, use of contraceptive agents must have been continued after completing the double-blind portion of the study.
  • Substudy:
  • Subjects must meet ALL inclusion criteria to be enrolled.
  • Subjects who provided written informed consent prior to initiation of any substudy-specific activities/procedures and are willing to comply with all substudy visits and substudy procedures.
  • Completion of OL extension treatment through Week 48 visit or treated with atrasentan long enough to sufficiently determine its efficacy as per clinical judgement of the Principal Investigator.
  • Stable on a maximally tolerated dose of ACEi and/or ARB for at least 12 weeks prior to substudy screening visit.
  • All fertile men and WOCBP who engage in heterosexual intercourse must be willing to abide with highly effective forms of contraception, as specified in the protocol

Who cannot join

  • Double-blind period:
  • Concurrent diagnosis of another cause of chronic kidney disease including diabetic kidney disease or another primary glomerulopathy.
  • Clinical diagnosis of nephrotic syndrome.
  • BNP value of > 200 pg/mL at Screening.
  • Platelet count <80,000 per μL at Screening.
  • History of organ transplantation (subjects with history of corneal transplant are not excluded).
Show all 40Show fewer
  • Use of systemic immunosuppressant medications.
  • Hemoglobin below 9 g/dL at Screening or prior history of blood transfusion for anemia within 3 months of Screening.
  • Open-label period:
  • eGFR < 25 mL/min/1.73m^2 or evidence of rapidly decreasing eGFR, including unrecovered acute kidney injury or expected to require renal replacement therapy within 3 months
  • BNP value of > 200 pg/mL at OL Screening.
  • Platelet count < 80,000 per μL at OL Screening.
  • Hemoglobin below 9 g/dL at OL screening or prior history of blood transfusion for anemia within 3 months of OL Screening.
  • Substudy:
  • Subjects must meet NONE of the following exclusion criteria to be enrolled.
  • Participants who are not receiving atrasentan at the time of substudy screening visit in the ALIGN OL extension study phase or had atrasentan interruption for longer than 2 weeks within last 24 weeks of substudy screening visit.
  • ALIGN OL extension participants with insufficient compliance defined as less than 70%
  • Plan to receive any investigational agent (other than atrasentan or zigakibart) or approved treatment for IgAN (other than a RAS inhibitor or SGLT2i). Other ETA receptor antagonists will not be allowed during substudy extension.
  • eGFR < 25 mL/min/1.73m2 or evidence of rapidly decreasing eGFR, including unrecovered acute kidney injury or expected to require renal replacement therapy within 3 months
  • Ongoing treatment-related SAE or ongoing related severe AESI.
  • Clinical suspicion of rapidly progressive glomerulonephritis (RPGN).
  • Received a live vaccination within 12 weeks prior to first substudy treatment administration in the substudy or plan to have a live vaccination within 6 months after the last dose of substudy treatment.
  • BNP value of > 200 pg/mL at substudy Screening.
  • Blood pressure >150 mmHg systolic or >95 mmHg diastolic at screening
  • Known history of heart failure or conditions relating to fluid overload.
  • Known history of clinically significant liver disease or transaminase or bilirubin values more than twice the upper limit of normal at substudy screening.
  • Type 1 diabetes; for type 2 diabetes, exclusion if HbA1c >8%, evidence of diabetic changes on kidney biopsy performed for any reason, or history of diabetic microvascular/macrovascular disease
  • Hemoglobin below 9 g/dL at substudy screening or prior history of blood transfusion for anemia within 3 months of substudy Screening.
  • Newly diagnosed or history of malignancy.
  • Pregnancy, breast feeding, or intent to become pregnant during the substudy period and until 24 weeks after last dose for females.
  • Intent to father a child or donate sperm during the substudy period and until 24 weeks after last dose for males.
  • History of an alcohol or illicit drug-related disorder within the past 3 years.
  • History or evidence of any other clinically significant medical disorder, condition, disease, or laboratory finding that, in the discretion of the Investigator, constitutes an uncertain or unfavorable benefit-risk for continued long-term therapy with zigakibart.
  • Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy.
  • Current severe infection at the time of first substudy treatment in the substudy or history of recurrent, severe, infections as determined by the Investigator.
  • Any confirmed or suspected immunosuppressive or immune-deficient state.
  • Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody positive but have documentation of negative HCV polymerase chain reaction [PCR] will be allowed), or antibodies to HIV-1 and/or HIV-2.
  • Prior exposure to any therapy directed against APRIL.
  • History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
  • Screening weight <45 kg or >150 kg

Trial locations and contacts

135 sites in 20 countries.

135 sites in 20 countries

United States21 sites

  • Comprehensive Research Institute

    Alhambra, California, 91754

  • Mountain Kidney and Hypertension Associates

    Asheville, North Carolina, 28801

  • Lehigh Valley Hospital

    Bethlehem, Pennsylvania, 18017

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Capital District Renal Physicians

    Clifton Park, New York, 12065

  • Liberty Research Center

    Dallas, Texas, 75230

  • El Paso Kidney Specialists

    El Paso, Texas, 79925

  • Nephrology Associates Of Northern Virginia

    Fairfax, Virginia, 22033

  • NANI Research, LLC

    Fort Wayne, Indiana, 46804

  • University of Florida

    Gainesville, Florida, 32610

  • Kidney Disease Medical Group

    Glendale, California, 91204

  • NANI Research, LLC

    Hinsdale, Illinois, 60521

  • Pelican Point Dialysis - DaVita Clinical Research

    Las Vegas, Nevada, 89129

  • GA Nephrology Associates

    Lawrenceville, Georgia, 30046

  • University of Louisville Physicians- Kidney Disease Program

    Louisville, Kentucky, 40202

  • Intermed Consultants

    Minneapolis, Minnesota, 55404

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Swedish Health Services

    Seattle, Washington, 98104

  • Stanford University

    Stanford, California, 93405

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

China19 sites

  • The First A ffliated Hospital of Baotou Medical College, Inner Mangolia University of Science and Technology

    Baotou, Inner Mongolia Autonomou, 014010

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 100044

  • The Second Hospital of Jilin University

    Changchun

  • The Third Xiangya Hospital of Central South University

    Changsha

  • People's Hospital of Sichuan Province

    Chengdu, Sichuan, 610072

  • West China Hospital, Sichuan University

    Chengdu

  • Dongguan Tungwah Hospital

    Dongguan, Dongguan

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • Nanfang Hospital of Southern Medical University

    Guangzhou

  • The Second Hospital of Anhui Medical University

    Hefei, 230601

  • Shandong University - Qilu Hospital

    Jinan

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

  • The First Affiliated Hospital Xinjiang Medical University

    Ürümqi, Xinjiang Uygur, 830054

Other trials in China

Japan13 sites

  • Kokura Memorial Hospital (Kokura Kinen Hospital)

    Fukuoka

  • Kanazawa University Hospital

    Kanazawa

  • Nara University

    Kashihara

  • St. Marianna University (SMU) School of Medicine

    Kawasaki

  • Niigata University

    Niigata

  • Okayama University Hospital

    Okayama

  • Osaka General Medical Center

    Osaka

  • Dokkyo Medical University - Saitama Medical Center

    Saitama

  • Showa University Hospital

    Shinagawa-ku

  • Juntendo Nerima Hospital

    Tokyo

  • Juntendo University Hospital, Tokyo

    Tokyo

  • Fujita Health University Hospital

    Toyoake

  • Juntendo University Urayasu Hospital

    Urayasu

Other trials in Japan

South Korea9 sites

  • Hallym University Medical Center

    Anyang

  • Chungnam National University Hospital

    Daejeon

  • Myongji Hospital

    Gyeonggi-do, 10475

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Jeju National University Hospital

    Jeju City

  • CHA Bundang Medical Center, CHA University

    Seongnam-si

  • Korea University Anam Hospital

    Seoul

  • Kyung Hee University Hospital at Gangdong

    Seoul

  • Severance Hospital, Yonsei University Hospital

    Seoul

Other trials in South Korea

Australia8 sites

  • Box Hill Hospital

    Box Hill

  • Royal Brisbane & Women's Hospital

    Brisbane

  • Monash Medical Centre

    Clayton

  • Renal Research

    Gosford

  • Nepean Hospital

    Kingswood

  • Melbourne Renal Research Group

    Reservoir, Victoria, 3073

  • Sunshine Hospital

    Saint Albans, Victoria, 3021

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Brazil7 sites

  • Hospital das Clínicas Universidade Federal de Minas Gerais - UFMG

    Belo Horizonte

  • Centro de Pesquisa Clinica do Brasil

    Brasília

  • Instituto Pró-Renal Brasil

    Curitiba, Paraná

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre

  • Praxis Pesquisa Médica

    Santo André

  • Hospital das Clinicas da Faculdade de Medicina da USP

    São Paulo

  • Hospital do Rim Fundacao Oswaldo Ramos

    São Paulo

Other trials in Brazil

United Kingdom7 sites

  • North Bristol HNS Trust, Clinical Research Centre

    Bristol, BS10 5NB

  • Lister Hospital

    Hertford

  • Leicester General Hospital

    Leicester, LE5 4PW

  • King's College Hospital

    London, SE5 9R6

  • Guys Hospital

    London

  • Royal London Hospital

    London

  • Salford Royal

    Salford

Other trials in United Kingdom

Germany6 sites

  • St. Josefs-Hospital

    Cloppenburg

  • Medizinische Hochschule Hannover

    Hanover

  • Nephrologisches Zentrum Hoyerswerda

    Hoyerswerda

  • Universitaetsklinikum Jena

    Jena

  • Nephrologisches Zentrum Villingen-Schwenningen

    Villingen-Schwenningen

  • Universitaetsklinikum Wuerzburg

    Würzburg

Other trials in Germany

India6 sites

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

  • Nil Ratan Sircar Medical College & Hospital

    Kolkata, West Bengal, 700014

  • Government Medical College

    Kozhikode, Kerala, 673008

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra, 411004

  • Yashoda Hospital

    Secunderabad, Telangana, 500003

  • Christian Medical College

    Vellore, Tamil Nadu, 632004

Other trials in India

Spain6 sites

  • Fundacion Puigvert

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario 12 De Octubre

    Madrid

  • Hospital de Sagunto

    Sagunto

  • Hospital Universitario Virgen Macarena

    Seville

  • H U Dr. Peset

    Valencia

Other trials in Spain

France5 sites

  • CHU de Grenoble - Hopital Albert Michallon

    Grenoble

  • CH Emile Roux

    Le Puy-en-Velay

  • Hopital Necker

    Paris

  • CHU Saint Etienne - Hopital Nord

    Saint-Priest-en-Jarez

  • Centre Hospitalier Valenciennes

    Valenciennes

Other trials in France

Taiwan5 sites

  • Changhua Christian Medical Foundation

    Changhua

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu

  • Far Eastern Memorial Hospital

    New Taipei City

  • Taipei Medical University

    New Taipei City

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

Argentina4 sites

  • CEMIC

    Buenos Aires

  • Hospital Britanico de Buenos Aires

    Buenos Aires

  • Centro Médico Ce.Re.Ca

    San Luis, San Luis Province, D5700CGR

  • Clinica de Nefrologia Urologia y Enf. Cardiovasculares

    Santa Fe

Other trials in Argentina

Hong Kong4 sites

  • Princess Margaret Hospital

    Hong Kong

  • The University of Hong Kong

    Hong Kong

  • Yan Chai Hospital

    Hong Kong

  • The Chinese University of Hong Kong

    Shatin

Other trials in Hong Kong

Italy4 sites

  • Azienda Ospedaliero Universitaria San Martino

    Genova

  • Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • Seconda Università degli Studi di Napoli

    Naples

  • ICS Maugeri SpA SB

    Pavia

Other trials in Italy

Poland3 sites

  • Samodzielny Publiczny ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego

    Lodz

  • Centrum Medyczne Medyk - Rzeszow

    Rzeszów

  • Miedzyleski Szpital Specjalistyczny

    Warsaw

Other trials in Poland

Canada2 sites

  • London Health Sciences Centre

    London, Ontario

  • Stephen S. Chow Medicine Professionals

    Toronto, Ontario

Other trials in Canada

Colombia2 sites

  • IPS Medicos Internistas de Caldas S.A.S

    Manizales, Caldas Department, 170004

  • Hospital Alma Mater de Antioquia

    Medellín, Antioquia, 050010

Other trials in Colombia

New Zealand2 sites

  • Waikato Hospital

    Hamilton

  • Middlemore Clinical Trials

    Papatoetoe

Other trials in New Zealand

Portugal2 sites

  • Centro Hospitalar de Lisboa Ocidental EPE - Hospital Santa Cruz

    Carnaxide, 2790-134

  • Centro Hospitalar do Medio Tejo (CHMT), E.P.E.

    Torres Novas, 2350-399

Other trials in Portugal

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function

The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.

Read the detailed description

Approximately 320 patients with biopsy-proven IgAN will be randomized to receive 0.75 mg atrasentan or placebo daily for 132 weeks. Subjects receive a maximally tolerated and stable dose of a RAS (renin-angiotensin system) inhibitor [such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)] as part of standard of care. An exception will be made for subjects who are unable to tolerate RAS inhibitor therapy.

Additional subjects receiving a stable dose of SGLT2i will be enrolled to the study. Enrollment in this SGLT2i stable stratum will be in accordance with local regulations in regions that prescribe SGLT2i and will be independent of the 320 subjects enrolled for the primary and secondary analyses.

The primary objective of the study is to evaluate the effect of atrasentan versus placebo on proteinuria as measured by UPCR. Secondary and tertiary objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability.

Subjects will have assessments of safety and efficacy over 2 ½ years. To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.

Subjects who complete treatment through Week 132 and complete the double-blinded portion of the study may be eligible to enroll in the open label (OL) extension of the study to receive atrasentan 0.75 mg daily for up to 48 weeks.

Subjects who complete the 48 weeks of atrasentan treatment in OL extension or who are treated with atrasentan long enough to sufficiently determine its efficacy as per clinical judgement of the Principal Investigator may be optionally re-evaluated for eligibility to participate in the substudy if available at their clinical site. Eligible subjects following re-evaluation may enter the co-administration treatment phase, receiving atrasentan 0.75 mg orally once daily plus zigakibart for 48 weeks.

Being tested
Atrasentan, Placebo, Zigakibart
Keywords
Kidney Diseases, Kidney Disease, Chronic, Urologic Diseases, Glomerulonephritis, Glomerular Disease, Glomerulonephritis, IGA, Glomerulopathy, Immunoglobulin Disease
Medical subject headings
Glomerulonephritis, IGA, Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases, Glomerulonephritis

What participants receive

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

  • AtrasentanDrug

    Also called CHK-01, Atrasentan Hydrochloride, ABT-627

    Film-coated tablet

  • PlaceboDrug

    Film-coated tablet

  • ZigakibartDrug

    Also called FUB523, BION-1301

    pre-filled syringes with needle safety device

Study groups in NCT04573478
Study groupRoleWhat they receive
AtrasentanExperimentalDouble-blind Period: Once daily oral administration of 0.75 mg atrasentan for 132 weeks. Open-label Extension Period: Once daily oral administration of 0.75 mg atrasentan for 48 weeks after completion of 132 weeks on atrasentan or placebo. Substudy period: Once daily oral administration of 0.75 mg atrasentan + zigakibart for 48 weeks after completion of OL extension period
Receives: Drug: Atrasentan; Drug: Zigakibart
PlaceboPlacebo comparatorDouble-blind Period: Once daily oral administration of placebo for 132 weeks
Receives: Drug: Placebo

What is being measured

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

  1. Double-blind period: Change in proteinuria

    The change in urine protein:creatinine ratio (UPCR) from baseline to Week 36. (non-SGLT2i stratum)

    Measured: Up to Week 36 or approximately 9 months

  2. Open-label period: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)

    Type, incidence, severity, seriousness, and relatedness of TEAEs.

    Measured: From open-label baseline up to end of treatment visit, up to 48 weeks

  3. Open-label period: Number of Subjects With Adverse Events of Special Interest (AESI) Including Events of Fluid Overload

    Incidence, severity, seriousness, and relatedness AESIs.

    Measured: From open-label baseline up to end of treatment visit, up to 48 weeks

  4. Substudy period: Number of subjects with TEAEs

    Type, incidence, severity, seriousness, and relatedness of TEAEs

    Measured: From substudy baseline to end of treatment, up to 48 weeks

  5. Substudy period: Number of subjects with AESI

    Incidence, severity, seriousness, and relatedness AESIs.

    Measured: From substudy baseline to end of treatment, up to 48 weeks

Secondary outcomes (8)

  1. Double-blind period: Change in eGFR

    Change from Baseline to final study visit (Week 136, 4 weeks post end of treatment) using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation (non-SGLT2i stratum)

    Measured: Up to Week 136, 4 weeks post end of treatment

  2. Double-blind period: Percent of subjects meeting the first composite endpoint

    Percent of subjects in the non-SGLT2i stratum meeting the composite endpoint of experiencing at least one of the following during the study:

    • At least a 30% reduction in eGFR sustained for at least 30 days
    • eGFR <15 mL/min/1.73m^2, sustained for at least 30 days
    • Chronic dialysis ≥30 days
    • Kidney transplantation
    • All-cause mortality

    Measured: Up to approximately 2.6 years

  3. Double-blind period: Percent of subjects meeting the second composite endpoint

    Percent of subjects in the non-SGLT2i stratum meeting the composite endpoint of experiencing at least one of the following during the study:

    • At least a 40% reduction in eGFR sustained for at least 30 days
    • eGFR <15 mL/min/1.73m^2, sustained for at least 30 days
    • Chronic dialysis ≥30 days
    • Kidney transplantation
    • All-cause mortality

    Measured: Up to approximately 2.6 years

  4. Double-blind period: Percent of subjects achieving reduction of proteinuria to < 1 g/day at Week 36

    Percentage of subjects with reduction of proteinuria to < 1 g/day and a 25% decrease in total urine protein from Baseline (non-SGLT2i stratum).

    Measured: Baseline to Week 36

  5. Double-blind period: Number of Subjects With TEAEs

    Type, incidence, severity, seriousness, and relatedness of TEAEs.

    Measured: From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks

  6. Double-blind period: Number of Subjects With AESI Including Events of Fluid Overload

    Incidence, severity, seriousness, and relatedness AESIs.

    Measured: From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks

  7. Open-label period: Change in proteinuria

    Change in UPCR based on 24-hour urine collection.

    Measured: Open-label Baseline to open-label Week 36

  8. Open-label period: Change in eGFR

    Change from open-label Baseline to open-label Week 52 using the CKD-EPI creatinine equation.

    Measured: Open-label Baseline to open-label Week 52

Timeline

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

  1. First posted5 Oct 2020
  2. Study start11 Dec 2020
  3. Primary completion14 Apr 2028 (estimated)
  4. Study completion14 Apr 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04573478
Sponsor's protocol ID
CHK01-01
Other IDs
CEXV811A12301
Acronym
ALIGN
Status last verified
May 2026
First submitted
12 Sep 2020
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heerspink HJL, Jardine MJ, Kohan DE, Lafayette R, Levin A, Liew A, Zhang H, Noronha IL, Mastroianni-Kirsztajn G, Chow S, Choi DE, Lv J, Trimarchi H, Fu P, Guenther S, Yang S, Liu J, Rahalkar S, Lodha A, Dahlke M, Kollins D, Barratt J; ALIGN study group. Atrasentan in patients with IgA nephropathy (ALIGN): final 2.5-year results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2026 Jun 13;407(10546):2387-2401. doi: 10.1016/S0140-6736(26)00960-8. Epub 2026 Jun 4.

    PubMed 42242268

  • Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.

    PubMed 41661687

  • Kuo JJ, Wu J, Gunawan MG, McConnell MT, Lester J, Naidu NA, Nieh CH, Surendradoss J, Kano T, Suzuki Y, Olson NE, Cox JH. Effects of Atrasentan on Kidney Gene Transcription, Mesangial Cell Proliferation, and Proteinuria in IgA Nephropathy. Kidney360. 2026 May 1;7(5):1003-1016. doi: 10.34067/KID.0000001000. Epub 2025 Dec 24.

    PubMed 41442197

  • Heerspink HJL, Jardine M, Kohan DE, Lafayette RA, Levin A, Liew A, Zhang H, Lodha A, Gray T, Wang Y, Renfurm R, Barratt J; ALIGN Study Investigators. Atrasentan in Patients with IgA Nephropathy. N Engl J Med. 2025 Feb 6;392(6):544-554. doi: 10.1056/NEJMoa2409415. Epub 2024 Oct 25.

    PubMed 39460694

  • Schiffrin EL, Pollock DM. Endothelin System in Hypertension and Chronic Kidney Disease. Hypertension. 2024 Apr;81(4):691-701. doi: 10.1161/HYPERTENSIONAHA.123.21716. Epub 2023 Dec 7.

    PubMed 38059359

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atrasentan and Zigakibart in people with IgA Nephropathy and Immunoglobulin A Nephropathy, run by Novartis Pharmaceuticals at 135 sites in 20 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 18 inclusion and 40 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, China, Japan, South Korea, Australia and 15 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Double-blind period: Change in proteinuria (time frame: Up to Week 36 or approximately 9 months). The study lists 5 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 NCT04573478, which also lists 5 linked publications.

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 4 Jun 2026.

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