Atrasentan in Patients With IgA Nephropathy (ALIGN)

June 1, 2026 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • CEMIC
      • Buenos Aires, Argentina
        • Hospital Británico de Buenos Aires
      • Santa Fe, Argentina
        • Clinica de Nefrologia Urologia y Enf. Cardiovasculares
    • San Luis Province
      • San Luis, San Luis Province, Argentina, D5700CGR
        • Centro Médico Ce.Re.Ca
  • Australia
      • Box Hill, Australia
        • Box Hill Hospital
      • Brisbane, Australia
        • Royal Brisbane & Women's Hospital
      • Clayton, Australia
        • Monash Medical Centre
      • Gosford, Australia
        • Renal Research
      • Kingswood, Australia
        • Nepean Hospital
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Victoria
      • Reservoir, Victoria, Australia, 3073
        • Melbourne Renal Research Group
      • Saint Albans, Victoria, Australia, 3021
        • Sunshine Hospital
  • Brazil
      • Belo Horizonte, Brazil
        • Hospital das Clínicas Universidade Federal de Minas Gerais - UFMG
      • Brasília, Brazil
        • Centro de Pesquisa Clinica do Brasil
      • Porto Alegre, Brazil
        • Santa Casa de Misericórdia de Porto Alegre
      • Santo André, Brazil
        • Praxis Pesquisa Médica
      • São Paulo, Brazil
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • São Paulo, Brazil
        • Hospital do Rim Fundacao Oswaldo Ramos
    • Paraná
      • Curitiba, Paraná, Brazil
        • Instituto Pró-Renal Brasil
  • Canada
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Toronto, Ontario, Canada
        • Stephen S. Chow Medicine Professionals
  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Changchun, China
        • The Second Hospital of Jilin University
      • Changsha, China
        • The Third XIANGYA Hospital of Central South University
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Fuzhou, China
        • The First Affiliated Hospital of Fujian Medical University
      • Guangzhou, China
        • Nanfang Hospital of Southern Medical University
      • Hefei, China, 230601
        • The Second Hospital of Anhui Medical University
      • Jinan, China
        • Shandong University - Qilu Hospital
      • Nanchang, China
        • The First Affiliated Hospital of Nanchang University
      • Shenzhen, China, 518036
        • Peking University Shenzhen Hospital
    • Dongguan
      • Dongguan, Dongguan, China
        • Dongguan Tungwah Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
    • Inner Mongolia Autonomou
      • Baotou, Inner Mongolia Autonomou, China, 014010
        • The First A ffliated Hospital of Baotou Medical College, Inner Mangolia University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Nantong, Jiangsu, China, 226001
        • The Affiliated Hospital of Nantong University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Renji Hospital Shanghai Jiaotong University School of Medicine
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • People's Hospital of Sichuan Province
    • Xinjiang Uygur
      • Ürümqi, Xinjiang Uygur, China, 830054
        • The First Affiliated Hospital Xinjiang Medical University
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050010
        • Hospital Alma Máter de Antioquia
    • Caldas Department
      • Manizales, Caldas Department, Colombia, 170004
        • IPS Medicos Internistas de Caldas S.A.S
  • France
      • Grenoble, France
        • CHU de Grenoble - Hôpital Albert Michallon
      • Le Puy-en-Velay, France
        • CH Emile Roux
      • Paris, France
        • Hopital Necker
      • Saint-Priest-en-Jarez, France
        • CHU Saint Etienne - Hôpital Nord
      • Valenciennes, France
        • Centre Hospitalier Valenciennes
  • Germany
      • Cloppenburg, Germany
        • St. Josefs-Hospital
      • Hanover, Germany
        • Medizinische Hochschule Hannover
      • Hoyerswerda, Germany
        • Nephrologisches Zentrum Hoyerswerda
      • Jena, Germany
        • Universitaetsklinikum Jena
      • Villingen-Schwenningen, Germany
        • Nephrologisches Zentrum Villingen-Schwenningen
      • Würzburg, Germany
        • Universitaetsklinikum Wuerzburg
  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Hong Kong, Hong Kong
        • Yan Chai Hospital
      • Shatin, Hong Kong
        • The Chinese University of Hong Kong
  • India
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Government Medical College
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Sahyadri Super Speciality Hospital
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College
    • Telangana
      • Hyderabad, Telangana, India, 500012
        • Osmania General Hospital
      • Secunderabad, Telangana, India, 500003
        • Yashoda Hospital
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • Nil Ratan Sircar Medical College & Hospital
  • Italy
      • Genova, Italy
        • Azienda Ospedaliero Universitaria San Martino
      • Naples, Italy
        • Seconda Università degli Studi di Napoli
      • Pavia, Italy
        • ICS Maugeri SpA SB
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Japan
      • Fukuoka, Japan
        • Kokura Memorial Hospital (Kokura Kinen Hospital)
      • Kanazawa, Japan
        • Kanazawa University Hospital
      • Kashihara, Japan
        • Nara University
      • Kawasaki, Japan
        • St. Marianna University (SMU) School of Medicine
      • Niigata, Japan
        • Niigata University
      • Okayama, Japan
        • Okayama University Hospital
      • Osaka, Japan
        • Osaka General Medical Center
      • Saitama, Japan
        • Dokkyo Medical University - Saitama Medical Center
      • Shinagawa-ku, Japan
        • Showa University Hospital
      • Tokyo, Japan
        • Juntendo Nerima Hospital
      • Tokyo, Japan
        • Juntendo University Hospital, Tokyo
      • Toyoake, Japan
        • Fujita Health University Hospital
      • Urayasu, Japan
        • Juntendo University Urayasu Hospital
  • New Zealand
      • Hamilton, New Zealand
        • Waikato Hospital
      • Papatoetoe, New Zealand
        • Middlemore Clinical Trials
  • Poland
      • Lodz, Poland
        • Samodzielny Publiczny ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego
      • Rzeszów, Poland
        • Centrum Medyczne Medyk - Rzeszow
      • Warsaw, Poland
        • Miedzyleski Szpital Specjalistyczny
  • Portugal
      • Carnaxide, Portugal, 2790-134
        • Centro Hospitalar de Lisboa Ocidental EPE - Hospital Santa Cruz
      • Torres Novas, Portugal, 2350-399
        • Centro Hospitalar do Medio Tejo (CHMT), E.P.E.
  • South Korea
      • Anyang, South Korea
        • Hallym University Medical Center
      • Daejeon, South Korea
        • Chungnam National University Hospital
      • Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, South Korea, 10475
        • MyongJi Hospital
      • Jeju City, South Korea
        • Jeju National University Hospital
      • Seongnam-si, South Korea
        • CHA Bundang Medical Center, CHA University
      • Seoul, South Korea
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Kyung Hee University Hospital at Gangdong
      • Seoul, South Korea
        • Severance Hospital, Yonsei University Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Fundación Puigvert
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Sagunto, Spain
        • Hospital de Sagunto
      • Seville, Spain
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain
        • H U Dr. Peset
  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Medical Foundation
      • Hsinchu, Taiwan
        • National Taiwan University Hospital Hsin-Chu Branch
      • New Taipei City, Taiwan
        • Far Eastern Memorial Hospital
      • New Taipei City, Taiwan
        • Taipei Medical University
      • Taipei, Taiwan
        • National Taiwan University Hospital
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • North Bristol HNS Trust, Clinical Research Centre
      • Hertford, United Kingdom
        • Lister Hospital
      • Leicester, United Kingdom, LE5 4PW
        • Leicester General Hospital
      • London, United Kingdom
        • Guys Hospital
      • London, United Kingdom
        • Royal London Hospital
      • London, United Kingdom, SE5 9R6
        • King's College Hospital
      • Salford, United Kingdom
        • Salford Royal
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Alhambra, California, United States, 91754
        • Comprehensive Research Institute
      • Glendale, California, United States, 91204
        • Kidney Disease Medical Group
      • Stanford, California, United States, 93405
        • Stanford University
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • GA Nephrology Associates
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • NANI Research, LLC
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • NANI Research, LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Physicians- Kidney Disease Program
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Intermed Consultants
    • Nevada
      • Las Vegas, Nevada, United States, 89129
        • Pelican Point Dialysis - DaVita Clinical Research
    • New York
      • Clifton Park, New York, United States, 12065
        • Capital District Renal Physicians
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mountain Kidney and Hypertension Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Brookview Hills Research Associates, LLC
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • LeHigh Valley Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75230
        • Liberty Research Center
      • El Paso, Texas, United States, 79925
        • El Paso Kidney Specialists
    • Virginia
      • Fairfax, Virginia, United States, 22033
        • Nephrology Associates of Northern Virginia
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Double-blind Period: Once daily oral administration of placebo for 132 weeks
Drug: Placebo
Film-coated tablet
Experimental: Atrasentan

Double-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
Drug: Atrasentan
Film-coated tablet
Other Names:
  • ABT-627
  • CHK-01
  • Atrasentan Hydrochloride
Drug: Zigakibart
pre-filled syringes with needle safety device
Other Names:
  • FUB523
  • BION-1301

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double-blind period: Change in proteinuria
Time Frame: Up to Week 36 or approximately 9 months
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 36. (non-SGLT2i stratum)
Up to Week 36 or approximately 9 months
Open-label period: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From open-label baseline up to end of treatment visit, up to 48 weeks
Type, incidence, severity, seriousness, and relatedness of TEAEs.
From open-label baseline up to end of treatment visit, up to 48 weeks
Open-label period: Number of Subjects With Adverse Events of Special Interest (AESI) Including Events of Fluid Overload
Time Frame: From open-label baseline up to end of treatment visit, up to 48 weeks
Incidence, severity, seriousness, and relatedness AESIs.
From open-label baseline up to end of treatment visit, up to 48 weeks
Substudy period: Number of subjects with TEAEs
Time Frame: From substudy baseline to end of treatment, up to 48 weeks
Type, incidence, severity, seriousness, and relatedness of TEAEs
From substudy baseline to end of treatment, up to 48 weeks
Substudy period: Number of subjects with AESI
Time Frame: From substudy baseline to end of treatment, up to 48 weeks
Incidence, severity, seriousness, and relatedness AESIs.
From substudy baseline to end of treatment, up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double-blind period: Change in eGFR
Time Frame: Up to Week 136, 4 weeks post end of treatment
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)
Up to Week 136, 4 weeks post end of treatment
Double-blind period: Percent of subjects meeting the first composite endpoint
Time Frame: Up to approximately 2.6 years

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
Up to approximately 2.6 years
Double-blind period: Percent of subjects meeting the second composite endpoint
Time Frame: Up to approximately 2.6 years

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
Up to approximately 2.6 years
Double-blind period: Percent of subjects achieving reduction of proteinuria to < 1 g/day at Week 36
Time Frame: Baseline to 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).
Baseline to Week 36
Double-blind period: Number of Subjects With TEAEs
Time Frame: From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks
Type, incidence, severity, seriousness, and relatedness of TEAEs.
From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks
Double-blind period: Number of Subjects With AESI Including Events of Fluid Overload
Time Frame: From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks
Incidence, severity, seriousness, and relatedness AESIs.
From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks
Open-label period: Change in proteinuria
Time Frame: Open-label Baseline to open-label Week 36
Change in UPCR based on 24-hour urine collection.
Open-label Baseline to open-label Week 36
Open-label period: Change in eGFR
Time Frame: Open-label Baseline to open-label Week 52
Change from open-label Baseline to open-label Week 52 using the CKD-EPI creatinine equation.
Open-label Baseline to open-label Week 52

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proteinuria (UPCR)
Time Frame: Baseline to Week 36
1. Change in proteinuria (UPCR) based on 24-hour urine collection in SGLT2i stable stratum compared to Placebo
Baseline to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2020

Primary Completion (Estimated)

April 14, 2028

Study Completion (Estimated)

April 14, 2028

Study Registration Dates

First Submitted

September 12, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHK01-01
  • CEXV811A12301 (Other Identifier: Novartis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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