RecruitingPhase 2NCT06902558

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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Sponsor

Calico Life Sciences LLC

Enrollment

240 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

Autosomal Dominant Polycystic Kidney Disease

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ABBV-CLS-628 and a drug called Placebo for people with autosomal dominant polycystic kidney disease. The study is currently recruiting participants at 75 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABBV-CLS-628

IntraVenous Infusion

DRUGPlacebo

IntraVenous Infusion

Locations(75)

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

Garden Grove, California, United States

Valiance Clinical Research - Huntington Park /ID# 270634

Huntington Park, California, United States

Academic Medical Research Institute - Los Angeles /ID# 270502

Los Angeles, California, United States

UC Irvine Medical Center /ID# 270811

Orange, California, United States

University Of California, San Francisco /ID# 270326

San Francisco, California, United States

Yale University School of Medicine /ID# 270675

New Haven, Connecticut, United States

Horizon Research Group - Coral Gables /ID# 270857

Coral Gables, Florida, United States

South Florida Research Institute /ID# 270848

Fort Lauderdale, Florida, United States

Nature Coast Clinical Research - Inverness /ID# 270875

Inverness, Florida, United States

Mayo Clinic Hospital Jacksonville /ID# 271011

Jacksonville, Florida, United States

Panax Clinical Research /ID# 270851

Miami, Florida, United States

Infigo Clinical Research /ID# 270844

Sanford, Florida, United States

Emory University School Of Medicine - Atlanta /ID# 271947

Atlanta, Georgia, United States

CARE-Boise Kidney /ID# 270628

Boise, Idaho, United States

CARE Institute - Idaho Falls /ID# 272005

Idaho Falls, Idaho, United States

Northwestern University Feinberg School of Medicine /ID# 271409

Chicago, Illinois, United States

University of Iowa /ID# 270492

Iowa City, Iowa, United States

University of Kansas Medical Center /ID# 271946

Kansas City, Kansas, United States

Tufts Medical Center /ID# 270323

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center /ID# 271408

Boston, Massachusetts, United States

University Of Michigan /ID# 270436

Ann Arbor, Michigan, United States

St. Clair Nephrology /ID# 271445

Shelby, Michigan, United States

Mayo Clinic Hospital Rochester /ID# 270428

Rochester, Minnesota, United States

Washington University /ID# 271436

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai /ID# 271440

New York, New York, United States

University of North Carolina at Chapel Hill /ID# 274800

Chapel Hill, North Carolina, United States

Brookview Hills Research Associates /ID# 271449

Winston-Salem, North Carolina, United States

Northeast Clinical Research Center /ID# 270838

Bethlehem, Pennsylvania, United States

University of Pennsylvania /ID# 270301

Philadelphia, Pennsylvania, United States

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

Chattanooga, Tennessee, United States

Knoxville Kidney Center /ID# 270706

Knoxville, Tennessee, United States

Arlington Nephrology /ID# 270494

Arlington, Texas, United States

Renal Disease Research Institute /ID# 270339

Fort Worth, Texas, United States

University of Virginia /ID# 270329

Charlottesville, Virginia, United States

Swedish Medical Center - Seattle /ID# 270344

Seattle, Washington, United States

Westmead Hospital /ID# 271156

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital /ID# 271224

Brisbane, Queensland, Australia

Royal Adelaide Hospital /ID# 273114

Adelaide, South Australia, Australia

Fiona Stanley Hospital /ID# 271173

Murdoch, Western Australia, Australia

Cliniques Universitaires UCL Saint-Luc /ID# 270635

Brussels, Brussels Capital, Belgium

UZ Leuven /ID# 270638

Leuven, Vlaams-Brabant, Belgium

CHU de Liege /ID# 270631

Liège, Belgium

Hopital Edouard Herriot /ID# 271142

Lyon, Auvergne-Rhône-Alpes, France

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

Brest, Brittany Region, France

CHU Toulouse - Hôpital Rangueil /ID# 271138

Toulouse, Occitanie, France

Hopital de la Conception /ID# 271152

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

Hopital Universitaire Necker Enfants Malades /ID# 271146

Paris, Île-de-France Region, France

TUM Klinikum rechts der Isar /ID# 271522

Munich, Bavaria, Germany

Medizinische Hochschule Hannover /ID# 270938

Hanover, Lower Saxony, Germany

Universitaetsklinikum Koeln /ID# 270937

Cologne, North Rhine-Westphalia, Germany

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935

Berlin, Germany

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563

Rome, Roma, Italy

Hokkaido University Hospital /ID# 271385

Sapporo, Hokkaido, Japan

National Hospital Organization Kyoto Medical Center /ID# 271782

Kyoto, Kyoto, Japan

Juntendo University Hospital /ID# 271722

Bunkyo-ku, Tokyo, Japan

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

Chiba, Japan

Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247

Dordrecht, South Holland, Netherlands

Lumc /Id# 271844

Leiden, South Holland, Netherlands

Universitair Medisch Centrum Groningen /ID# 271249

Groningen, Netherlands

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

Almada, Setúbal District, Portugal

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

Braga, Portugal

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

Faro, Portugal

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

Lisbon, Portugal

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

Lisbon, Portugal

Pusan National University Hospital /ID# 271429

Busan, Busan Gwang Yeogsi, South Korea

Keimyung University Dongsan Hospital /ID# 272455

Daegu, Gyeongsangbuk-do, South Korea

Seoul National University Hospital /ID# 271331

Seoul, Seoul Teugbyeolsi, South Korea

SMG-SNU Boramae Medical Center /ID# 271227

Seoul, Seoul Teugbyeolsi, South Korea

Hallym University Kangnam Sacred Heart Hospital /ID# 271329

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Universitari de Bellvitge /ID# 270489

L'Hospitalet de Llobregat, Barcelona, Spain

Fundacio Puigvert /ID# 270491

Barcelona, Spain

Hospital Universitario Virgen de las Nieves /ID# 270918

Granada, Spain

Hospital Universitario Fundacion Jimenez Diaz /ID# 270485

Madrid, Spain

Hospital Universitario 12 de Octubre /ID# 270829

Madrid, Spain

Hospital Clínico Universitario de Valencia /ID# 270837

Valencia, Spain

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NCT06902558

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