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A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Sponsor: AbbVie
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
2026-02-04
Healthy Volunteers
No
Interventions
ABBV-CLS-628
IntraVenous Infusion
Placebo
IntraVenous Infusion
Locations (75)
National Institute of Clinical Research - Garden Grove /ID# 271418
Garden Grove, California, United States
Valiance Clinical Research - Huntington Park /ID# 270634
Huntington Park, California, United States
Academic Medical Research Institute - Los Angeles /ID# 270502
Los Angeles, California, United States
UC Irvine Medical Center /ID# 270811
Orange, California, United States
University Of California, San Francisco /ID# 270326
San Francisco, California, United States
Yale University School of Medicine /ID# 270675
New Haven, Connecticut, United States
Horizon Research Group - Coral Gables /ID# 270857
Coral Gables, Florida, United States
South Florida Research Institute /ID# 270848
Fort Lauderdale, Florida, United States
Nature Coast Clinical Research - Inverness /ID# 270875
Inverness, Florida, United States
Mayo Clinic Hospital Jacksonville /ID# 271011
Jacksonville, Florida, United States
Panax Clinical Research /ID# 270851
Miami, Florida, United States
Infigo Clinical Research /ID# 270844
Sanford, Florida, United States
Emory University School Of Medicine - Atlanta /ID# 271947
Atlanta, Georgia, United States
CARE-Boise Kidney /ID# 270628
Boise, Idaho, United States
CARE Institute - Idaho Falls /ID# 272005
Idaho Falls, Idaho, United States
Northwestern University Feinberg School of Medicine /ID# 271409
Chicago, Illinois, United States
University of Iowa /ID# 270492
Iowa City, Iowa, United States
University of Kansas Medical Center /ID# 271946
Kansas City, Kansas, United States
Tufts Medical Center /ID# 270323
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 271408
Boston, Massachusetts, United States
University Of Michigan /ID# 270436
Ann Arbor, Michigan, United States
St. Clair Nephrology /ID# 271445
Shelby, Michigan, United States
Mayo Clinic Hospital Rochester /ID# 270428
Rochester, Minnesota, United States
Washington University /ID# 271436
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai /ID# 271440
New York, New York, United States
University of North Carolina at Chapel Hill /ID# 274800
Chapel Hill, North Carolina, United States
Brookview Hills Research Associates /ID# 271449
Winston-Salem, North Carolina, United States
Northeast Clinical Research Center /ID# 270838
Bethlehem, Pennsylvania, United States
University of Pennsylvania /ID# 270301
Philadelphia, Pennsylvania, United States
Nephrology Associates - Chattanooga - East Third Street /ID# 270701
Chattanooga, Tennessee, United States
Knoxville Kidney Center /ID# 270706
Knoxville, Tennessee, United States
Arlington Nephrology /ID# 270494
Arlington, Texas, United States
Renal Disease Research Institute /ID# 270339
Fort Worth, Texas, United States
University of Virginia /ID# 270329
Charlottesville, Virginia, United States
Swedish Medical Center - Seattle /ID# 270344
Seattle, Washington, United States
Westmead Hospital /ID# 271156
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital /ID# 271224
Brisbane, Queensland, Australia
Royal Adelaide Hospital /ID# 273114
Adelaide, South Australia, Australia
Fiona Stanley Hospital /ID# 271173
Murdoch, Western Australia, Australia
Cliniques Universitaires UCL Saint-Luc /ID# 270635
Brussels, Brussels Capital, Belgium
UZ Leuven /ID# 270638
Leuven, Vlaams-Brabant, Belgium
CHU de Liege /ID# 270631
Liège, Belgium
Hopital Edouard Herriot /ID# 271142
Lyon, Auvergne-Rhône-Alpes, France
CHU Brest - Hôpital de la Cavale Blanche /ID# 271114
Brest, Brittany Region, France
CHU Toulouse - Hôpital Rangueil /ID# 271138
Toulouse, Occitanie, France
Hopital de la Conception /ID# 271152
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hopital Universitaire Necker Enfants Malades /ID# 271146
Paris, Île-de-France Region, France
TUM Klinikum rechts der Isar /ID# 271522
Munich, Bavaria, Germany
Medizinische Hochschule Hannover /ID# 270938
Hanover, Lower Saxony, Germany
Universitaetsklinikum Koeln /ID# 270937
Cologne, North Rhine-Westphalia, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935
Berlin, Germany
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563
Rome, Roma, Italy
Hokkaido University Hospital /ID# 271385
Sapporo, Hokkaido, Japan
National Hospital Organization Kyoto Medical Center /ID# 271782
Kyoto, Kyoto, Japan
Juntendo University Hospital /ID# 271722
Bunkyo-ku, Tokyo, Japan
National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 272022
Chiba, Japan
Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247
Dordrecht, South Holland, Netherlands
Lumc /Id# 271844
Leiden, South Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 271249
Groningen, Netherlands
Unidade Local de Saude de Almada-Seixal, EPE /ID# 271257
Almada, Setúbal District, Portugal
2CA-Braga, Hospital de Braga /ID# 271258
Braga, Portugal
Unidade Local de Saude do Algarve, EPE /ID# 271819
Faro, Portugal
Unidade Local de Saude de Sao Jose, EPE /ID# 271255
Lisbon, Portugal
Unidade Local de Saude de Lisboa Ocidental, EPE /ID# 271261
Lisbon, Portugal
Pusan National University Hospital /ID# 271429
Busan, Busan Gwang Yeogsi, South Korea
Keimyung University Dongsan Hospital /ID# 272455
Daegu, Gyeongsangbuk-do, South Korea
Seoul National University Hospital /ID# 271331
Seoul, Seoul Teugbyeolsi, South Korea
SMG-SNU Boramae Medical Center /ID# 271227
Seoul, Seoul Teugbyeolsi, South Korea
Hallym University Kangnam Sacred Heart Hospital /ID# 271329
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitari de Bellvitge /ID# 270489
L'Hospitalet de Llobregat, Barcelona, Spain
Fundacio Puigvert /ID# 270491
Barcelona, Spain
Hospital Universitario Virgen de las Nieves /ID# 270918
Granada, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 270485
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 270829
Madrid, Spain
Hospital Clínico Universitario de Valencia /ID# 270837
Valencia, Spain