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NCT06902558PHASE2Recruiting

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

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Valiance Clinical Research - Huntington Park

Huntington Park, California 90255

United States

Academic Medical Research Institute (AMRI) - Los Angeles

Los Angeles, California 90022

United States

UC Irvine Medical Center

Orange, California 92868-3201

United States

National Institute of Clinical Research - Pomona

Pomona, California 91768

United States

University Of California, San Francisco

San Francisco, California 94143-2202

United States

University of California Los Angeles Medical Center

Santa Monica, California 90404

United States

Yale University School of Medicine

New Haven, Connecticut 06510

United States

Horizon Research Group - Coral Gables

Coral Gables, Florida 33134

United States

South Florida Research Institute

Fort Lauderdale, Florida 33313

United States

Nature Coast Clinical Research - Inverness

Inverness, Florida 34452-4717

United States

Mayo Clinic Hospital Jacksonville

Jacksonville, Florida 32224

United States

Panax Clinical Research

Miami, Florida 33014

United States

University of Miami Don Suffer Clinical Research Building

Miami, Florida 33136

United States

Infigo Clinical Research

Sanford, Florida 32771

United States

Emory University School Of Medicine - Atlanta

Atlanta, Georgia 30322

United States

CARE-Boise Kidney

Boise, Idaho 83706

United States

CARE Institute - Idaho Falls

Idaho Falls, Idaho 83404

United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois 60611-2927

United States

University of Iowa

Iowa City, Iowa 52242

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Tufts Medical Center

Boston, Massachusetts 02111-1552

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

University Of Michigan

Ann Arbor, Michigan 48109-5000

United States

St. Clair Nephrology

Shelby, Michigan 48315

United States

Mayo Clinic Hospital - Rochester

Rochester, Minnesota 55905

United States

Washington University School of Medicine - St Louis

St Louis, Missouri 63110

United States

Rogosin Institute

New York, New York 10021

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599-0001

United States

Brookview Hills Research Associates

Winston-Salem, North Carolina 27103

United States

Northeast Clinical Research Center

Bethlehem, Pennsylvania 18017

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Nephrology Associates - Chattanooga - East Third Street

Chattanooga, Tennessee 37404

United States

Knoxville Kidney Center

Knoxville, Tennessee 37923

United States

The Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee 37212

United States

Arlington Nephrology

Arlington, Texas 76015

United States

Renal Disease Research Institute

Dallas, Texas 75204

United States

Swedish Medical Center - Seattle

Seattle, Washington 98104

United States

Westmead Hospital

Westmead, New South Wales 2145

Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland 4029

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Fiona Stanley Hospital

Murdoch, Western Australia 6150

Australia

Cliniques Universitaires UCL Saint-Luc

Brussels, Brussels Capital 1200

Belgium

CHU de Liege

Liège, Liège 4000

Belgium

UZ Leuven

Leuven, Vlaams-Brabant 3000

Belgium

Lakeridge Health Corporation-Oshawa

Oshawa, Ontario L1H 2B9

Canada

Humber River Hospital

Toronto, Ontario M3M 0B2

Canada

St. Michael's Hospital

Toronto, Ontario M5B 1W8

Canada

Toronto General Hospital-University Health Network

Toronto, Ontario M5G 2C4

Canada

Hopital Edouard Herriot

Lyon, Auvergne-Rhône-Alpes 69003

France

CHU Brest - Hôpital de la Cavale Blanche

Brest, Brittany Region 29200

France

CHU Toulouse - Hôpital Rangueil

Toulouse, Occitanie 31400

France

Hopital de la Conception

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

France

Hopital Universitaire Necker Enfants Malades

Paris, Île-de-France Region 75015

France

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg 69120

Germany

TUM Klinikum rechts der Isar

Munich, Bavaria 81675

Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony 30625

Germany

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia 50937

Germany

Charite Universitaetsmedizin Berlin - Campus Mitte

Berlin, State of Berlin 10117

Germany

A.O.U. Consorziale Policlinico di Bari

Bari, Metropolitan City of Bari 70124

Italy

AOU di Modena - Ospedale di Modena

Modena, Modena 41124

Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, Roma 00161

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica

Rome, Roma 00168

Italy

National Hospital Org Chiba Medical Center Chibahigashi National Hospital

Chiba, Chiba 260-8712

Japan

Hokkaido University Hospital

Sapporo, Hokkaido 060-8648

Japan

National Hospital Organization Kyoto Medical Center

Kyoto, Kyoto 612-8555

Japan

Juntendo University Hospital

Bunkyō-Ku, Tokyo 113-8431

Japan

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen 9713 GR

Netherlands

Albert Schweitzer Ziekenhuis, locatie Dordwijk

Dordrecht, South Holland 3318 AT

Netherlands

LUMC

Leiden, South Holland 2333 ZA

Netherlands

Erasmus Medisch Centrum

Rotterdam, South Holland 3015 AA

Netherlands

2CA-Braga, Hospital de Braga

Braga, Braga District 4710-243

Portugal

Unidade Local de Saude do Algarve, EPE

Faro, Faro District 8000-386

Portugal

Hospital Curry Cabral

Lisbon, Lisbon District 1069-166

Portugal

Unidade Local de Saude de Lisboa Ocidental, EPE

Lisbon, Lisbon District 2799-523

Portugal

Unidade Local de Saude de Almada-Seixal, EPE

Almada, Setúbal District 2805-267

Portugal

Centro Hospitalar Do Funchal

Funchal, 9000-168

Portugal

Pusan National University Hospital

Busan, Busan Gwang Yeogsi 49241

South Korea

Keimyung University Dongsan Hospital

Daegu, Gyeongsangbuk-do 42601

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

SMG-SNU Boramae Medical Center

Seoul, Seoul Teugbyeolsi 07061

South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul Teugbyeolsi 07441

South Korea

Fundacio Puigvert

Barcelona, Barcelona 08025

Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona 08907

Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada 18014

Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Madrid 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid 28041

Spain

Hospital Universitario Virgen del Rocio

Seville, Sevilla 41013

Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia 46010

Spain