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)
NCT ID: NCT06902558
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2025-06-09
2029-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ABBV-CLS-628 Dose A
Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
ABBV-CLS-628
IntraVenous Infusion
ABBV-CLS-628 Dose B
Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
ABBV-CLS-628
IntraVenous Infusion
ABBV-CLS-628 Dose C
Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
ABBV-CLS-628
IntraVenous Infusion
Placebo
Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
Placebo
IntraVenous Infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABBV-CLS-628
IntraVenous Infusion
Placebo
IntraVenous Infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73 m\^2 and \< 90 mL/min/1.73 m\^2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening.
Exclusion Criteria
* Any exclusionary medical diseases, disorders, or conditions as described in the protocol.
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Calico Life Sciences LLC
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
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 Kansas Medical Center /ID# 271946
Kansas City, Kansas, United States
Tufts Medical Center /ID# 270323
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
Brookview Hills Research Associates /ID# 271449
Winston-Salem, North Carolina, United States
Northeast Clinical Research Center /ID# 270838
Bethlehem, 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
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
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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-517143-31-00
Identifier Type: OTHER
Identifier Source: secondary_id
M25-147
Identifier Type: -
Identifier Source: org_study_id