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ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Calico Life Sciences LLC

Start Date

6/9/2025

Completion Date

8/1/2029

Summary

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants. ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide. Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria

Age Range: 18 years to 55 years

Inclusion Criteria: * Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD. * Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73 m\^2 and \< 90 mL/min/1.73 m\^2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening. Exclusion Criteria: * Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications. * Any exclusionary medical diseases, disorders, or conditions as described in the protocol.

Interventions

DRUG

ABBV-CLS-628

DRUG

Placebo

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Conditions

Autosomal Dominant Polycystic Kidney Disease

Locations

National Institute of Clinical Research - Garden Grove /ID# 271418

Garden Grove, California 92844

United States

Valiance Clinical Research - Huntington Park /ID# 270634

Huntington Park, California 90255

United States

Academic Medical Research Institute - Los Angeles /ID# 270502

Los Angeles, California 90022

United States

UC Irvine Medical Center /ID# 270811

Orange, California 92868-3201

United States

University Of California, San Francisco /ID# 270326

San Francisco, California 94143-2202

United States

Yale University School of Medicine /ID# 270675

New Haven, Connecticut 06510

United States

Horizon Research Group - Coral Gables /ID# 270857

Coral Gables, Florida 33134

United States

South Florida Research Institute /ID# 270848

Fort Lauderdale, Florida 33313

United States

Nature Coast Clinical Research - Inverness /ID# 270875

Inverness, Florida 34452-4717

United States

Mayo Clinic Hospital Jacksonville /ID# 271011

Jacksonville, Florida 32224

United States

Panax Clinical Research /ID# 270851

Miami, Florida 33014

United States

Infigo Clinical Research /ID# 270844

Sanford, Florida 32771

United States

Emory University School Of Medicine - Atlanta /ID# 271947

Atlanta, Georgia 30322

United States

CARE-Boise Kidney /ID# 270628

Boise, Idaho 83706

United States

CARE Institute - Idaho Falls /ID# 272005

Idaho Falls, Idaho 83404

United States

Northwestern University Feinberg School of Medicine /ID# 271409

Chicago, Illinois 60611-2927

United States

University of Iowa /ID# 270492

Iowa City, Iowa 52242

United States

University of Kansas Medical Center /ID# 271946

Kansas City, Kansas 66160

United States

Tufts Medical Center /ID# 270323

Boston, Massachusetts 02111-1552

United States

Beth Israel Deaconess Medical Center /ID# 271408

Boston, Massachusetts 02215

United States

University Of Michigan /ID# 270436

Ann Arbor, Michigan 48109-5000

United States

St. Clair Nephrology /ID# 271445

Shelby, Michigan 48315

United States

Mayo Clinic Hospital Rochester /ID# 270428

Rochester, Minnesota 55905

United States

Washington University /ID# 271436

St Louis, Missouri 63110

United States

Icahn School of Medicine at Mount Sinai /ID# 271440

New York, New York 10029

United States

University of North Carolina at Chapel Hill /ID# 274800

Chapel Hill, North Carolina 27599-0001

United States

Brookview Hills Research Associates /ID# 271449

Winston-Salem, North Carolina 27103

United States

Northeast Clinical Research Center /ID# 270838

Bethlehem, Pennsylvania 18017

United States

University of Pennsylvania /ID# 270301

Philadelphia, Pennsylvania 19104

United States

Nephrology Associates - Chattanooga - East Third Street /ID# 270701

Chattanooga, Tennessee 37404

United States

Knoxville Kidney Center /ID# 270706

Knoxville, Tennessee 37923

United States

Arlington Nephrology /ID# 270494

Arlington, Texas 76015

United States

Renal Disease Research Institute /ID# 270339

Fort Worth, Texas 76104

United States

University of Virginia /ID# 270329

Charlottesville, Virginia 22908

United States

Swedish Medical Center - Seattle /ID# 270344

Seattle, Washington 98104

United States

Westmead Hospital /ID# 271156

Westmead, New South Wales 2145

Australia

Royal Brisbane and Women's Hospital /ID# 271224

Brisbane, Queensland 4029

Australia

Royal Adelaide Hospital /ID# 273114

Adelaide, South Australia 5000

Australia

Fiona Stanley Hospital /ID# 271173

Murdoch, Western Australia 6150

Australia

Cliniques Universitaires UCL Saint-Luc /ID# 270635

Brussels, Brussels Capital 1200

Belgium

UZ Leuven /ID# 270638

Leuven, Vlaams-Brabant 3000

Belgium

CHU de Liege /ID# 270631

Liège, 4000

Belgium

Hopital Edouard Herriot /ID# 271142

Lyon, Auvergne-Rhône-Alpes 69003

France

CHU Brest - Hôpital de la Cavale Blanche /ID# 271114

Brest, Brittany Region 29200

France

CHU Toulouse - Hôpital Rangueil /ID# 271138

Toulouse, Occitanie 31400

France

Hopital de la Conception /ID# 271152

Marseille, Provence-Alpes-Côte d'Azur Region 13005

France

Hopital Universitaire Necker Enfants Malades /ID# 271146

Paris, Île-de-France Region 75015

France

TUM Klinikum rechts der Isar /ID# 271522

Munich, Bavaria 81675

Germany

Medizinische Hochschule Hannover /ID# 270938

Hanover, Lower Saxony 30625

Germany

Universitaetsklinikum Koeln /ID# 270937

Cologne, North Rhine-Westphalia 50937

Germany

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935

Berlin, 10117

Germany

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563

Rome, Roma 00161

Italy

Hokkaido University Hospital /ID# 271385

Sapporo, Hokkaido 060-8648

Japan

National Hospital Organization Kyoto Medical Center /ID# 271782

Kyoto, Kyoto 612-8555

Japan

Juntendo University Hospital /ID# 271722

Bunkyo-ku, Tokyo 113-8431

Japan

National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 272022

Chiba, 260-8712

Japan

Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247

Dordrecht, South Holland 3318 AT

Netherlands

Lumc /Id# 271844

Leiden, South Holland 2333 ZA

Netherlands

Universitair Medisch Centrum Groningen /ID# 271249

Groningen, 9713 GR

Netherlands

Unidade Local de Saude de Almada-Seixal, EPE /ID# 271257

Almada, Setúbal District 2805-267

Portugal

2CA-Braga, Hospital de Braga /ID# 271258

Braga, 4710-243

Portugal

Unidade Local de Saude do Algarve, EPE /ID# 271819

Faro, 8000-386

Portugal

Unidade Local de Saude de Sao Jose, EPE /ID# 271255

Lisbon, 1150-199

Portugal

Unidade Local de Saude de Lisboa Ocidental, EPE /ID# 271261

Lisbon, 1449-005

Portugal

Pusan National University Hospital /ID# 271429

Busan, Busan Gwang Yeogsi 49241

South Korea

Keimyung University Dongsan Hospital /ID# 272455

Daegu, Gyeongsangbuk-do 42601

South Korea

Seoul National University Hospital /ID# 271331

Seoul, Seoul Teugbyeolsi 03080

South Korea

SMG-SNU Boramae Medical Center /ID# 271227

Seoul, Seoul Teugbyeolsi 07061

South Korea

Hallym University Kangnam Sacred Heart Hospital /ID# 271329

Seoul, Seoul Teugbyeolsi 07441

South Korea

Hospital Universitari de Bellvitge /ID# 270489

L'Hospitalet de Llobregat, Barcelona 08907

Spain

Fundacio Puigvert /ID# 270491

Barcelona, 08025

Spain

Hospital Universitario Virgen de las Nieves /ID# 270918

Granada, 18014

Spain

Hospital Universitario Fundacion Jimenez Diaz /ID# 270485

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre /ID# 270829

Madrid, 28041

Spain

Hospital Clínico Universitario de Valencia /ID# 270837

Valencia, 46010

Spain