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)

Status: Recruiting
Location: See all (62) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

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

• 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.

Locations
United States
California
National Institute of Clinical Research - Garden Grove /ID# 271418
RECRUITING
Garden Grove
Valiance Clinical Research - Huntington Park /ID# 270634
RECRUITING
Huntington Park
Academic Medical Research Institute - Los Angeles /ID# 270502
RECRUITING
Los Angeles
UC Irvine Medical Center /ID# 270811
RECRUITING
Orange
Connecticut
Yale University School of Medicine /ID# 270675
RECRUITING
New Haven
Florida
Horizon Research Group - Coral Gables /ID# 270857
RECRUITING
Coral Gables
South Florida Research Institute /ID# 270848
RECRUITING
Fort Lauderdale
Nature Coast Clinical Research - Inverness /ID# 270875
RECRUITING
Inverness
Mayo Clinic Hospital Jacksonville /ID# 271011
RECRUITING
Jacksonville
Panax Clinical Research /ID# 270851
RECRUITING
Miami
Idaho
CARE-Boise Kidney /ID# 270628
RECRUITING
Boise
CARE Institute - Idaho Falls /ID# 272005
RECRUITING
Idaho Falls
Illinois
Northwestern University Feinberg School of Medicine /ID# 271409
RECRUITING
Chicago
Massachusetts
Tufts Medical Center /ID# 270323
RECRUITING
Boston
Michigan
University Of Michigan /ID# 270436
RECRUITING
Ann Arbor
St. Clair Nephrology /ID# 271445
RECRUITING
Shelby
Minnesota
Mayo Clinic Hospital Rochester /ID# 270428
RECRUITING
Rochester
Missouri
Washington University /ID# 271436
RECRUITING
St Louis
North Carolina
Brookview Hills Research Associates /ID# 271449
RECRUITING
Winston-salem
Pennsylvania
Northeast Clinical Research Center /ID# 270838
RECRUITING
Bethlehem
Tennessee
Nephrology Associates - Chattanooga - East Third Street /ID# 270701
RECRUITING
Chattanooga
Knoxville Kidney Center /ID# 270706
RECRUITING
Knoxville
Texas
Arlington Nephrology /ID# 270494
RECRUITING
Arlington
Renal Disease Research Institute /ID# 270339
RECRUITING
Fort Worth
Washington
Swedish Medical Center - Seattle /ID# 270344
RECRUITING
Seattle
Other Locations
Australia
Royal Adelaide Hospital /ID# 273114
RECRUITING
Adelaide
Royal Brisbane and Women's Hospital /ID# 271224
RECRUITING
Brisbane
Fiona Stanley Hospital /ID# 271173
RECRUITING
Murdoch
Westmead Hospital /ID# 271156
RECRUITING
Westmead
Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 270635
RECRUITING
Brussels
UZ Leuven /ID# 270638
RECRUITING
Leuven
CHU de Liege /ID# 270631
RECRUITING
Liège
France
CHU Brest - Hôpital de la Cavale Blanche /ID# 271114
RECRUITING
Brest
Hopital Edouard Herriot /ID# 271142
RECRUITING
Lyon
Hopital de la Conception /ID# 271152
RECRUITING
Marseille
CHU Toulouse - Hôpital Rangueil /ID# 271138
RECRUITING
Toulouse
Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935
RECRUITING
Berlin
Universitaetsklinikum Koeln /ID# 270937
RECRUITING
Cologne
Medizinische Hochschule Hannover /ID# 270938
RECRUITING
Hanover
Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563
RECRUITING
Rome
Japan
Juntendo University Hospital /ID# 271722
RECRUITING
Bunkyo-ku
National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 272022
RECRUITING
Chiba
National Hospital Organization Kyoto Medical Center /ID# 271782
RECRUITING
Kyoto
Hokkaido University Hospital /ID# 271385
RECRUITING
Sapporo
Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247
RECRUITING
Dordrecht
Universitair Medisch Centrum Groningen /ID# 271249
RECRUITING
Groningen
Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 271257
RECRUITING
Almada
2CA-Braga, Hospital de Braga /ID# 271258
RECRUITING
Braga
Unidade Local de Saude do Algarve, EPE /ID# 271819
RECRUITING
Faro
Unidade Local de Saude de Lisboa Ocidental, EPE /ID# 271261
RECRUITING
Lisbon
Unidade Local de Saude de Sao Jose, EPE /ID# 271255
RECRUITING
Lisbon
Republic of Korea
Pusan National University Hospital /ID# 271429
RECRUITING
Busan
Keimyung University Dongsan Hospital /ID# 272455
RECRUITING
Daegu
Hallym University Kangnam Sacred Heart Hospital /ID# 271329
RECRUITING
Seoul
Seoul National University Hospital /ID# 271331
RECRUITING
Seoul
SMG-SNU Boramae Medical Center /ID# 271227
RECRUITING
Seoul
Spain
Fundacio Puigvert /ID# 270491
RECRUITING
Barcelona
Hospital Universitario Virgen de las Nieves /ID# 270918
RECRUITING
Granada
Hospital Universitari de Bellvitge /ID# 270489
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario 12 de Octubre /ID# 270829
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz /ID# 270485
RECRUITING
Madrid
Hospital Clínico Universitario de Valencia /ID# 270837
RECRUITING
Valencia
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2029-08
Participants
Target number of participants: 240
Treatments
Experimental: ABBV-CLS-628 Dose A
Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
Experimental: ABBV-CLS-628 Dose B
Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
Experimental: ABBV-CLS-628 Dose C
Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
Placebo_comparator: Placebo
Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
Sponsors
Leads: AbbVie
Collaborators: Calico Life Sciences LLC

This content was sourced from clinicaltrials.gov