New drug aims to slow kidney failure in common kidney disease

NCT ID NCT04573478

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether the drug atrasentan can slow kidney function loss in people with IgA nephropathy, a disease that can lead to kidney failure. About 404 participants receive either atrasentan or a placebo, along with standard care. The main goal is to see if atrasentan reduces protein in the urine, a sign of kidney damage, over 36 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: atrasentan
What this could lead to: If successful, atrasentan could offer a new option to slow kidney damage and delay the need for dialysis or transplant in people with IgA nephropathy.
What could go wrong: This is a phase 3 trial, but results are not yet final. The drug may not prove effective enough, and side effects like fluid overload are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

404 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. * 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 Exclusion Criteria: 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). * 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

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Conditions

The condition(s) this trial relates to.

chronic renal failure syndrome glomerulonephritis IgA glomerulonephritis kidney disorder urinary system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IgA nephropathy Immunoglobulin A nephropathy

Contacts and locations

Locations

Azienda Ospedaliero Universitaria San Martino

Genova, Italy
Box Hill Hospital

Box Hill, Australia
Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, 27103, United States
CEMIC

Buenos Aires, Argentina
CH Emile Roux

Le Puy-en-Velay, France
CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea
CHU Saint Etienne - Hopital Nord

Saint-Priest-en-Jarez, France
CHU de Grenoble - Hopital Albert Michallon

Grenoble, France
Capital District Renal Physicians

Clifton Park, New York, 12065, United States
Centre Hospitalier Valenciennes

Valenciennes, France
Centro Hospitalar de Lisboa Ocidental EPE - Hospital Santa Cruz

Carnaxide, 2790-134, Portugal
Centro Hospitalar do Medio Tejo (CHMT), E.P.E.

Torres Novas, 2350-399, Portugal
Centro Médico Ce.Re.Ca

San Luis, San Luis Province, D5700CGR, Argentina
Centro de Pesquisa Clinica do Brasil

Brasília, Brazil
Centrum Medyczne Medyk - Rzeszow

Rzeszów, Poland
Changhua Christian Medical Foundation

Changhua, Taiwan
Christian Medical College

Vellore, Tamil Nadu, 632004, India
Chungnam National University Hospital

Daejeon, South Korea
Clinica de Nefrologia Urologia y Enf. Cardiovasculares

Santa Fe, Argentina
Comprehensive Research Institute

Alhambra, California, 91754, United States
Dokkyo Medical University - Saitama Medical Center

Saitama, Japan
Dongguan Tungwah Hospital

Dongguan, Dongguan, China
El Paso Kidney Specialists

El Paso, Texas, 79925, United States
Far Eastern Memorial Hospital

New Taipei City, Taiwan
Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy
Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China
Fujita Health University Hospital

Toyoake, Japan
Fundacion Puigvert

Barcelona, Spain
GA Nephrology Associates

Lawrenceville, Georgia, 30046, United States
Government Medical College

Kozhikode, Kerala, 673008, India
Guys Hospital

London, United Kingdom
H U Dr. Peset

Valencia, Spain
Hallym University Medical Center

Anyang, South Korea
Hopital Necker

Paris, France
Hospital Alma Mater de Antioquia

Medellín, Antioquia, 050010, Colombia
Hospital Britanico de Buenos Aires

Buenos Aires, Argentina
Hospital Universitari Vall d'Hebron

Barcelona, Spain
Hospital Universitario 12 De Octubre

Madrid, Spain
Hospital Universitario Virgen Macarena

Seville, Spain
Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, Brazil
Hospital das Clínicas Universidade Federal de Minas Gerais - UFMG

Belo Horizonte, Brazil
Hospital de Sagunto

Sagunto, Spain
Hospital do Rim Fundacao Oswaldo Ramos

São Paulo, Brazil
ICS Maugeri SpA SB

Pavia, Italy
IPS Medicos Internistas de Caldas S.A.S

Manizales, Caldas Department, 170004, Colombia
Instituto Pró-Renal Brasil

Curitiba, Paraná, Brazil
Intermed Consultants

Minneapolis, Minnesota, 55404, United States
Jeju National University Hospital

Jeju City, South Korea
Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China
Juntendo Nerima Hospital

Tokyo, Japan
Juntendo University Hospital, Tokyo

Tokyo, Japan
Juntendo University Urayasu Hospital

Urayasu, Japan
Kanazawa University Hospital

Kanazawa, Japan
Kidney Disease Medical Group

Glendale, California, 91204, United States
King's College Hospital

London, SE5 9R6, United Kingdom
Kokura Memorial Hospital (Kokura Kinen Hospital)

Fukuoka, Japan
Korea University Anam Hospital

Seoul, South Korea
Kyung Hee University Hospital at Gangdong

Seoul, South Korea
Lehigh Valley Hospital

Bethlehem, Pennsylvania, 18017, United States
Leicester General Hospital

Leicester, LE5 4PW, United Kingdom
Liberty Research Center

Dallas, Texas, 75230, United States
Lister Hospital

Hertford, United Kingdom
London Health Sciences Centre

London, Ontario, Canada
Medizinische Hochschule Hannover

Hanover, Germany
Melbourne Renal Research Group

Reservoir, Victoria, 3073, Australia
Middlemore Clinical Trials

Papatoetoe, New Zealand
Miedzyleski Szpital Specjalistyczny

Warsaw, Poland
Monash Medical Centre

Clayton, Australia
Mountain Kidney and Hypertension Associates

Asheville, North Carolina, 28801, United States
Myongji Hospital

Gyeonggi-do, 10475, South Korea
NANI Research, LLC

Hinsdale, Illinois, 60521, United States
NANI Research, LLC

Fort Wayne, Indiana, 46804, United States
Nanfang Hospital of Southern Medical University

Guangzhou, China
Nara University

Kashihara, Japan
National Taiwan University Hospital

Taipei, Taiwan
National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan
Nepean Hospital

Kingswood, Australia
Nephrologisches Zentrum Hoyerswerda

Hoyerswerda, Germany
Nephrologisches Zentrum Villingen-Schwenningen

Villingen-Schwenningen, Germany
Nephrology Associates Of Northern Virginia

Fairfax, Virginia, 22033, United States
Niigata University

Niigata, Japan
Nil Ratan Sircar Medical College & Hospital

Kolkata, West Bengal, 700014, India
North Bristol HNS Trust, Clinical Research Centre

Bristol, BS10 5NB, United Kingdom
Okayama University Hospital

Okayama, Japan
Osaka General Medical Center

Osaka, Japan
Osmania General Hospital

Hyderabad, Telangana, 500012, India
Peking University First Hospital

Beijing, 100034, China
Peking University People's Hospital

Beijing, 100044, China
Peking University Shenzhen Hospital

Shenzhen, 518036, China
Pelican Point Dialysis - DaVita Clinical Research

Las Vegas, Nevada, 89129, United States
People's Hospital of Sichuan Province

Chengdu, Sichuan, 610072, China
Praxis Pesquisa Médica

Santo André, Brazil
Princess Margaret Hospital

Hong Kong, Hong Kong
Renal Research

Gosford, Australia
Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China
Royal Brisbane & Women's Hospital

Brisbane, Australia
Royal London Hospital

London, United Kingdom
Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia
Sahyadri Super Speciality Hospital

Pune, Maharashtra, 411004, India
Salford Royal

Salford, United Kingdom
Samodzielny Publiczny ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego

Lodz, Poland
Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil
Seconda Università degli Studi di Napoli

Naples, Italy
Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea
Severance Hospital, Yonsei University Hospital

Seoul, South Korea
Shandong University - Qilu Hospital

Jinan, China
Showa University Hospital

Shinagawa-ku, Japan
St. Josefs-Hospital

Cloppenburg, Germany
St. Marianna University (SMU) School of Medicine

Kawasaki, Japan
Stanford University

Stanford, California, 93405, United States
Stephen S. Chow Medicine Professionals

Toronto, Ontario, Canada
Sunshine Hospital

Saint Albans, Victoria, 3021, Australia
Swedish Health Services

Seattle, Washington, 98104, United States
Taipei Medical University

New Taipei City, Taiwan
The Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China
The Chinese University of Hong Kong

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

Baotou, Inner Mongolia Autonomou, 014010, China
The First Affiliated Hospital Xinjiang Medical University

Ürümqi, Xinjiang Uygur, 830054, China
The First Affiliated Hospital of Fujian Medical University

Fuzhou, China
The First Affiliated Hospital of Nanchang University

Nanchang, China
The Second Hospital of Anhui Medical University

Hefei, 230601, China
The Second Hospital of Jilin University

Changchun, China
The Third Xiangya Hospital of Central South University

Changsha, China
The University of Hong Kong

Hong Kong, Hong Kong
Tufts Medical Center

Boston, Massachusetts, 02111, United States
Universitaetsklinikum Jena

Jena, Germany
Universitaetsklinikum Wuerzburg

Würzburg, Germany
University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States
University of Florida

Gainesville, Florida, 32610, United States
University of Louisville Physicians- Kidney Disease Program

Louisville, Kentucky, 40202, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Waikato Hospital

Hamilton, New Zealand
West China Hospital, Sichuan University

Chengdu, China
Yan Chai Hospital

Hong Kong, Hong Kong
Yashoda Hospital

Secunderabad, Telangana, 500003, India

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