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

Description

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.

Interventions

• ABBV-CLS-628 (Drug)
  IntraVenous Infusion
• Placebo (Drug)
  IntraVenous Infusion

Eligibility criteria

Conditions

Locations

• 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
• Rogosin Institute — New York, New York, 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 — Dallas, 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