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ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Sponsor: Calico Life Sciences LLC
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-06-09
Completion Date
2029-08
Last Updated
2026-08-05
Healthy Volunteers
No
Interventions
ABBV-CLS-628
IntraVenous Infusion
Placebo
IntraVenous Infusion
Locations (90)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Valiance Clinical Research - Huntington Park
Huntington Park, California, United States
Academic Medical Research Institute (AMRI) - Los Angeles
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
National Institute of Clinical Research - Pomona
Pomona, California, United States
University Of California, San Francisco
San Francisco, California, United States
University of California Los Angeles Medical Center
Santa Monica, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Horizon Research Group - Coral Gables
Coral Gables, Florida, United States
South Florida Research Institute
Fort Lauderdale, Florida, United States
Nature Coast Clinical Research - Inverness
Inverness, Florida, United States
Mayo Clinic Hospital Jacksonville
Jacksonville, Florida, United States
Panax Clinical Research
Miami, Florida, United States
University of Miami Don Suffer Clinical Research Building
Miami, Florida, United States
Infigo Clinical Research
Sanford, Florida, United States
Emory University School Of Medicine - Atlanta
Atlanta, Georgia, United States
CARE-Boise Kidney
Boise, Idaho, United States
CARE Institute - Idaho Falls
Idaho Falls, Idaho, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University Of Michigan
Ann Arbor, Michigan, United States
St. Clair Nephrology
Shelby, Michigan, United States
Mayo Clinic Hospital - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine - St Louis
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Brookview Hills Research Associates
Winston-Salem, North Carolina, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Nephrology Associates - Chattanooga - East Third Street
Chattanooga, Tennessee, United States
Knoxville Kidney Center
Knoxville, Tennessee, United States
The Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, United States
Arlington Nephrology
Arlington, Texas, United States
Renal Disease Research Institute
Fort Worth, Texas, United States
Swedish Medical Center - Seattle
Seattle, Washington, United States
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Cliniques Universitaires UCL Saint-Luc
Brussels, Brussels Capital, Belgium
CHU de Liege
Liège, Liège, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Lakeridge Health Corporation-Oshawa
Oshawa, Ontario, Canada
Humber River Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital-University Health Network
Toronto, Ontario, Canada
Hopital Edouard Herriot
Lyon, Auvergne-Rhône-Alpes, France
CHU Brest - Hôpital de la Cavale Blanche
Brest, Brittany Region, France
CHU Toulouse - Hôpital Rangueil
Toulouse, Occitanie, France
Hopital de la Conception
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hopital Universitaire Necker Enfants Malades
Paris, Île-de-France Region, France
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
TUM Klinikum rechts der Isar
Munich, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte
Berlin, State of Berlin, Germany
A.O.U. Consorziale Policlinico di Bari
Bari, Metropolitan City of Bari, Italy
AOU di Modena - Ospedale di Modena
Modena, Modena, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica
Rome, Roma, Italy
National Hospital Org Chiba Medical Center Chibahigashi National Hospital
Chiba, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Kyoto, Japan
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan
Universitair Medisch Centrum Groningen
Groningen, Provincie Groningen, Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, South Holland, Netherlands
LUMC
Leiden, South Holland, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands
2CA-Braga, Hospital de Braga
Braga, Braga District, Portugal
Unidade Local de Saude do Algarve, EPE
Faro, Faro District, Portugal
Hospital Curry Cabral
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Lisboa Ocidental, EPE
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Almada-Seixal, EPE
Almada, Setúbal District, Portugal
Centro Hospitalar Do Funchal
Funchal, Portugal
Pusan National University Hospital
Busan, Busan Gwang Yeogsi, South Korea
Keimyung University Dongsan Hospital
Daegu, Gyeongsangbuk-do, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Fundacio Puigvert
Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Sevilla, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain