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
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