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

Last updated: May 22, 2026
Sponsor: Calico Life Sciences LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Failure

Treatment

ABBV-CLS-628

Placebo

Clinical Study ID

NCT06902558
M25-147
2024-517143-31-00
  • Ages 18-55
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based onthe Mayo Clinic Imaging Classification of ADPKD.

  • Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m^2 and < 90mL/min/1.73 m^2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening.

Exclusion

Exclusion Criteria:

  • Current interventions to treat ADPKD such as non-approved medications or lifestylemodifications.

  • Any exclusionary medical diseases, disorders, or conditions as described in theprotocol.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: ABBV-CLS-628
Phase: 2
Study Start date:
June 09, 2025
Estimated Completion Date:
August 31, 2029

Connect with a study center

  • Westmead Hospital /ID# 271156

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Westmead Hospital /ID# 271156

    Westmead 2143973, New South Wales 2155400 2145
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital /ID# 271224

    Brisbane, Queensland 4029
    Australia

    Active - Recruiting

  • Royal Brisbane and Women's Hospital /ID# 271224

    Brisbane 2174003, Queensland 2152274 4029
    Australia

    Site Not Available

  • Royal Adelaide Hospital /ID# 273114

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital /ID# 273114

    Adelaide 2078025, South Australia 2061327 5000
    Australia

    Site Not Available

  • Fiona Stanley Hospital /ID# 271173

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital /ID# 271173

    Murdoch 8349091, Western Australia 2058645 6150
    Australia

    Site Not Available

  • Cliniques Universitaires UCL Saint-Luc /ID# 270635

    Brussels, Brussels Capital 1200
    Belgium

    Active - Recruiting

  • Cliniques Universitaires UCL Saint-Luc /ID# 270635

    Brussels 2800866, Brussels Capital 2800867 1200
    Belgium

    Site Not Available

  • UZ Leuven /ID# 270638

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • UZ Leuven /ID# 270638

    Leuven 2792482, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • CHU de Liege /ID# 270631

    Liège, 4000
    Belgium

    Active - Recruiting

  • CHU de Liege /ID# 270631

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • Hopital Edouard Herriot /ID# 271142

    Lyon, Auvergne-Rhône-Alpes 69003
    France

    Active - Recruiting

  • Hopital Edouard Herriot /ID# 271142

    Lyon 2996944, Auvergne-Rhône-Alpes 11071625 69003
    France

    Site Not Available

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

    Brest, Brittany Region 29200
    France

    Active - Recruiting

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

    Brest 3030300, Brittany Region 3030293 29200
    France

    Site Not Available

  • CHU Toulouse - Hôpital Rangueil /ID# 271138

    Toulouse, Occitanie 31400
    France

    Active - Recruiting

  • CHU Toulouse - Hôpital Rangueil /ID# 271138

    Toulouse 2972315, Occitanie 11071623 31400
    France

    Site Not Available

  • Hopital de la Conception /ID# 271152

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

    Active - Recruiting

  • Hopital de la Conception /ID# 271152

    Marseille 2995469, Provence-Alpes-Côte d'Azur Region 2985244 13005
    France

    Site Not Available

  • Hopital Universitaire Necker Enfants Malades /ID# 271146

    Paris, Île-de-France Region 75015
    France

    Active - Recruiting

  • Hopital Universitaire Necker Enfants Malades /ID# 271146

    Paris 2988507, Île-de-France Region 3012874 75015
    France

    Site Not Available

  • TUM Klinikum rechts der Isar /ID# 271522

    Munich, Bavaria 81675
    Germany

    Active - Recruiting

  • TUM Klinikum rechts der Isar /ID# 271522

    Munich 2867714, Bavaria 2951839 81675
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover /ID# 270938

    Hanover, Lower Saxony 30625
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover /ID# 270938

    Hanover 2910831, Lower Saxony 2862926 30625
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln /ID# 270937

    Cologne, North Rhine-Westphalia 50937
    Germany

    Active - Recruiting

  • Universitaetsklinikum Koeln /ID# 270937

    Cologne 2886242, North Rhine-Westphalia 2861876 50937
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935

    Berlin, 10117
    Germany

    Active - Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563

    Rome, Roma 00161
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563

    Rome 3169070, Roma 00161
    Italy

    Site Not Available

  • Hokkaido University Hospital /ID# 271385

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Hokkaido University Hospital /ID# 271385

    Sapporo 2128295, Hokkaido 2130037 060-8648
    Japan

    Site Not Available

  • National Hospital Organization Kyoto Medical Center /ID# 271782

    Kyoto, Kyoto 612-8555
    Japan

    Active - Recruiting

  • National Hospital Organization Kyoto Medical Center /ID# 271782

    Kyoto-shi, Kyoto 612-8555
    Japan

    Site Not Available

  • National Hospital Organization Kyoto Medical Center /ID# 271782

    Kyoto 1857910, Kyoto 1857907 612-8555
    Japan

    Site Not Available

  • Juntendo University Hospital /ID# 271722

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

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

    Chiba, 260-8712
    Japan

    Active - Recruiting

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

    Chiba 2113015, 260-8712
    Japan

    Site Not Available

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247

    Dordrecht, South Holland 3318 AT
    Netherlands

    Active - Recruiting

  • Lumc /Id# 271844

    Leiden, South Holland 2333 ZA
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247

    Dordrecht 2756669, South Holland 2743698 3318 AT
    Netherlands

    Site Not Available

  • Lumc /Id# 271844

    Leiden 2751773, South Holland 2743698 2333 ZA
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen /ID# 271249

    Groningen, 9713 GR
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Groningen /ID# 271249

    Groningen 2755251, 9713 GR
    Netherlands

    Site Not Available

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

    Almada, Setúbal District 2805-267
    Portugal

    Active - Recruiting

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

    Almada 2271961, Setúbal District 2262961 2805-267
    Portugal

    Site Not Available

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

    Braga, 4710-243
    Portugal

    Active - Recruiting

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

    Braga 2742032, 4710-243
    Portugal

    Site Not Available

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

    Faro, 8000-386
    Portugal

    Active - Recruiting

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

    Faro 2268339, 8000-386
    Portugal

    Site Not Available

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

    Lisboa, 1449-005
    Portugal

    Active - Recruiting

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

    Lisboa, 1150-199
    Portugal

    Site Not Available

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

    Lisbon, 1449-005
    Portugal

    Active - Recruiting

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

    Lisbon, 1150-199
    Portugal

    Active - Recruiting

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

    Lisbon 2267057, 1449-005
    Portugal

    Active - Recruiting

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

    Lisbon 2267057, 1150-199
    Portugal

    Site Not Available

  • Pusan National University Hospital /ID# 271429

    Busan, Busan Gwang Yeogsi 49241
    South Korea

    Active - Recruiting

  • Pusan National University Hospital /ID# 271429

    Busan 1838524, Busan Gwang Yeogsi 49241
    South Korea

    Site Not Available

  • Keimyung University Dongsan Hospital /ID# 272455

    Daegu, Gyeongsangbuk-do 42601
    South Korea

    Active - Recruiting

  • Hallym University Kangnam Sacred Heart Hospital /ID# 271329

    Seoul, Seoul Teugbyeolsi 07441
    South Korea

    Active - Recruiting

  • SMG-SNU Boramae Medical Center /ID# 271227

    Seoul, Seoul Teugbyeolsi 07061
    South Korea

    Active - Recruiting

  • Seoul National University Hospital /ID# 271331

    Seoul, Seoul Teugbyeolsi 03080
    South Korea

    Active - Recruiting

  • Hallym University Kangnam Sacred Heart Hospital /ID# 271329

    Seoul 1835848, Seoul Teugbyeolsi 07441
    South Korea

    Active - Recruiting

  • SMG-SNU Boramae Medical Center /ID# 271227

    Seoul 1835848, Seoul Teugbyeolsi 07061
    South Korea

    Active - Recruiting

  • Seoul National University Hospital /ID# 271331

    Seoul 1835848, Seoul Teugbyeolsi 03080
    South Korea

    Site Not Available

  • Hospital Universitari de Bellvitge /ID# 270489

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge /ID# 270489

    L'Hospitalet de Llobregat 3120619, Barcelona 08907
    Spain

    Site Not Available

  • Fundacio Puigvert /ID# 270491

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Fundacio Puigvert /ID# 270491

    Barcelona 3128760, 08025
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves /ID# 270918

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves /ID# 270918

    Granada 2517117, 18014
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre /ID# 270829

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 270485

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre /ID# 270829

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 270485

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia /ID# 270837

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia /ID# 270837

    Valencia 2509954, 46010
    Spain

    Site Not Available

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

    Garden Grove, California 92844
    United States

    Active - Recruiting

  • Valiance Clinical Research - Huntington Park /ID# 270634

    Huntington Park, California 90255
    United States

    Active - Recruiting

  • Academic Medical Research Institute - Los Angeles /ID# 270502

    Los Angeles, California 90022
    United States

    Active - Recruiting

  • UC Irvine Medical Center /ID# 270811

    Orange, California 92868-3201
    United States

    Active - Recruiting

  • University Of California, San Francisco /ID# 270326

    San Francisco, California 94143-2202
    United States

    Active - Recruiting

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

    Garden Grove 5351515, California 5332921 92844
    United States

    Site Not Available

  • Valiance Clinical Research - Huntington Park /ID# 270634

    Huntington Park 5358736, California 5332921 90255
    United States

    Site Not Available

  • Academic Medical Research Institute - Los Angeles /ID# 270502

    Los Angeles 5368361, California 5332921 90022
    United States

    Site Not Available

  • UC Irvine Medical Center /ID# 270811

    Orange 5379513, California 5332921 92868-3201
    United States

    Site Not Available

  • University Of California, San Francisco /ID# 270326

    San Francisco 5391959, California 5332921 94143-2202
    United States

    Site Not Available

  • Yale University School of Medicine /ID# 270675

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale University School of Medicine /ID# 270675

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Horizon Research Group - Coral Gables /ID# 270857

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • South Florida Research Institute /ID# 270848

    Fort Lauderdale, Florida 33313
    United States

    Active - Recruiting

  • Nature Coast Clinical Research - Inverness /ID# 270875

    Inverness, Florida 34452-4717
    United States

    Active - Recruiting

  • Mayo Clinic Hospital Jacksonville /ID# 271011

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Panax Clinical Research /ID# 270851

    Miami, Florida 33014
    United States

    Active - Recruiting

  • Infigo Clinical Research /ID# 270844

    Sanford, Florida 32771
    United States

    Active - Recruiting

  • Horizon Research Group - Coral Gables /ID# 270857

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Site Not Available

  • South Florida Research Institute /ID# 270848

    Fort Lauderdale 4155966, Florida 4155751 33313
    United States

    Site Not Available

  • Nature Coast Clinical Research - Inverness /ID# 270875

    Inverness 4159786, Florida 4155751 34452-4717
    United States

    Site Not Available

  • Mayo Clinic Hospital Jacksonville /ID# 271011

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Panax Clinical Research /ID# 270851

    Miami 4164138, Florida 4155751 33014
    United States

    Site Not Available

  • Infigo Clinical Research /ID# 270844

    Sanford 4172086, Florida 4155751 32771
    United States

    Site Not Available

  • Emory University School Of Medicine - Atlanta /ID# 271947

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University School Of Medicine - Atlanta /ID# 271947

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • CARE-Boise Kidney /ID# 270628

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • CARE Institute - Idaho Falls /ID# 272005

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • CARE-Boise Kidney /ID# 270628

    Boise 5586437, Idaho 5596512 83706
    United States

    Site Not Available

  • CARE Institute - Idaho Falls /ID# 272005

    Idaho Falls 5596475, Idaho 5596512 83404
    United States

    Site Not Available

  • Northwestern University Feinberg School of Medicine /ID# 271409

    Chicago, Illinois 60611-2927
    United States

    Active - Recruiting

  • Northwestern University Feinberg School of Medicine /ID# 271409

    Chicago 4887398, Illinois 4896861 60611-2927
    United States

    Site Not Available

  • University of Iowa /ID# 270492

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa /ID# 270492

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • University of Kansas Medical Center /ID# 271946

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kansas Medical Center /ID# 271946

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center /ID# 271408

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Tufts Medical Center /ID# 270323

    Boston, Massachusetts 02111-1552
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center /ID# 271408

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Tufts Medical Center /ID# 270323

    Boston 4930956, Massachusetts 6254926 02111-1552
    United States

    Active - Recruiting

  • University Of Michigan /ID# 270436

    Ann Arbor, Michigan 48109-5000
    United States

    Active - Recruiting

  • St. Clair Nephrology /ID# 271445

    Shelby, Michigan 48315
    United States

    Active - Recruiting

  • University Of Michigan /ID# 270436

    Ann Arbor 4984247, Michigan 5001836 48109-5000
    United States

    Site Not Available

  • St. Clair Nephrology /ID# 271445

    Shelby 5009586, Michigan 5001836 48315
    United States

    Site Not Available

  • Mayo Clinic Hospital Rochester /ID# 270428

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Hospital Rochester /ID# 270428

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Washington University /ID# 271436

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University /ID# 271436

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai /ID# 271440

    New York, New York 10029
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai /ID# 271440

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill /ID# 274800

    Chapel Hill, North Carolina 27599-0001
    United States

    Active - Recruiting

  • Brookview Hills Research Associates /ID# 271449

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill /ID# 274800

    Chapel Hill 4460162, North Carolina 4482348 27599-0001
    United States

    Site Not Available

  • Brookview Hills Research Associates /ID# 271449

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • Northeast Clinical Research Center /ID# 270838

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • University of Pennsylvania /ID# 270301

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Northeast Clinical Research Center /ID# 270838

    Bethlehem 5180225, Pennsylvania 6254927 18017
    United States

    Site Not Available

  • University of Pennsylvania /ID# 270301

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

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

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Knoxville Kidney Center /ID# 270706

    Knoxville, Tennessee 37923
    United States

    Active - Recruiting

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

    Chattanooga 4612862, Tennessee 4662168 37404
    United States

    Site Not Available

  • Knoxville Kidney Center /ID# 270706

    Knoxville 4634946, Tennessee 4662168 37923
    United States

    Site Not Available

  • Arlington Nephrology /ID# 270494

    Arlington, Texas 76015
    United States

    Active - Recruiting

  • Renal Disease Research Institute /ID# 270339

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Arlington Nephrology /ID# 270494

    Arlington 4671240, Texas 4736286 76015
    United States

    Site Not Available

  • Renal Disease Research Institute /ID# 270339

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • University of Virginia /ID# 270329

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • University of Virginia /ID# 270329

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Site Not Available

  • Swedish Medical Center - Seattle /ID# 270344

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Swedish Medical Center - Seattle /ID# 270344

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

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