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