Actively Recruiting
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)
Led by AbbVie · Updated on 2026-02-04
240
Participants Needed
75
Research Sites
216 weeks
Total Duration
On this page
Sponsors
A
AbbVie
Lead Sponsor
C
Calico Life Sciences LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 55 years
- Diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on Mayo Clinic Imaging Classification
- Estimated glomerular filtration rate (eGFR) between 30 and less than 90 mL/min/1.73 m² at screening using CKD-EPI equation
You will not qualify if you...
- Currently receiving non-approved medications or lifestyle treatments for ADPKD
- Presence of any medical disease, disorder, or condition listed as exclusionary in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 75 locations
1
National Institute of Clinical Research - Garden Grove /ID# 271418
Garden Grove, California, United States, 92844
Actively Recruiting
2
Valiance Clinical Research - Huntington Park /ID# 270634
Huntington Park, California, United States, 90255
Actively Recruiting
3
Academic Medical Research Institute - Los Angeles /ID# 270502
Los Angeles, California, United States, 90022
Actively Recruiting
4
UC Irvine Medical Center /ID# 270811
Orange, California, United States, 92868-3201
Actively Recruiting
5
University Of California, San Francisco /ID# 270326
San Francisco, California, United States, 94143-2202
Actively Recruiting
6
Yale University School of Medicine /ID# 270675
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Horizon Research Group - Coral Gables /ID# 270857
Coral Gables, Florida, United States, 33134
Actively Recruiting
8
South Florida Research Institute /ID# 270848
Fort Lauderdale, Florida, United States, 33313
Actively Recruiting
9
Nature Coast Clinical Research - Inverness /ID# 270875
Inverness, Florida, United States, 34452-4717
Actively Recruiting
10
Mayo Clinic Hospital Jacksonville /ID# 271011
Jacksonville, Florida, United States, 32224
Actively Recruiting
11
Panax Clinical Research /ID# 270851
Miami, Florida, United States, 33014
Actively Recruiting
12
Infigo Clinical Research /ID# 270844
Sanford, Florida, United States, 32771
Actively Recruiting
13
Emory University School Of Medicine - Atlanta /ID# 271947
Atlanta, Georgia, United States, 30322
Actively Recruiting
14
CARE-Boise Kidney /ID# 270628
Boise, Idaho, United States, 83706
Actively Recruiting
15
CARE Institute - Idaho Falls /ID# 272005
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
16
Northwestern University Feinberg School of Medicine /ID# 271409
Chicago, Illinois, United States, 60611-2927
Actively Recruiting
17
University of Iowa /ID# 270492
Iowa City, Iowa, United States, 52242
Actively Recruiting
18
University of Kansas Medical Center /ID# 271946
Kansas City, Kansas, United States, 66160
Actively Recruiting
19
Tufts Medical Center /ID# 270323
Boston, Massachusetts, United States, 02111-1552
Actively Recruiting
20
Beth Israel Deaconess Medical Center /ID# 271408
Boston, Massachusetts, United States, 02215
Actively Recruiting
21
University Of Michigan /ID# 270436
Ann Arbor, Michigan, United States, 48109-5000
Actively Recruiting
22
St. Clair Nephrology /ID# 271445
Shelby, Michigan, United States, 48315
Actively Recruiting
23
Mayo Clinic Hospital Rochester /ID# 270428
Rochester, Minnesota, United States, 55905
Actively Recruiting
24
Washington University /ID# 271436
St Louis, Missouri, United States, 63110
Actively Recruiting
25
Icahn School of Medicine at Mount Sinai /ID# 271440
New York, New York, United States, 10029
Actively Recruiting
26
University of North Carolina at Chapel Hill /ID# 274800
Chapel Hill, North Carolina, United States, 27599-0001
Actively Recruiting
27
Brookview Hills Research Associates /ID# 271449
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
28
Northeast Clinical Research Center /ID# 270838
Bethlehem, Pennsylvania, United States, 18017
Actively Recruiting
29
University of Pennsylvania /ID# 270301
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
Nephrology Associates - Chattanooga - East Third Street /ID# 270701
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
31
Knoxville Kidney Center /ID# 270706
Knoxville, Tennessee, United States, 37923
Actively Recruiting
32
Arlington Nephrology /ID# 270494
Arlington, Texas, United States, 76015
Actively Recruiting
33
Renal Disease Research Institute /ID# 270339
Fort Worth, Texas, United States, 76104
Actively Recruiting
34
University of Virginia /ID# 270329
Charlottesville, Virginia, United States, 22908
Actively Recruiting
35
Swedish Medical Center - Seattle /ID# 270344
Seattle, Washington, United States, 98104
Actively Recruiting
36
Westmead Hospital /ID# 271156
Westmead, New South Wales, Australia, 2145
Actively Recruiting
37
Royal Brisbane and Women's Hospital /ID# 271224
Brisbane, Queensland, Australia, 4029
Actively Recruiting
38
Royal Adelaide Hospital /ID# 273114
Adelaide, South Australia, Australia, 5000
Actively Recruiting
39
Fiona Stanley Hospital /ID# 271173
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
40
Cliniques Universitaires UCL Saint-Luc /ID# 270635
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
41
UZ Leuven /ID# 270638
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
42
CHU de Liege /ID# 270631
Liège, Belgium, 4000
Actively Recruiting
43
Hopital Edouard Herriot /ID# 271142
Lyon, Auvergne-Rhône-Alpes, France, 69003
Actively Recruiting
44
CHU Brest - Hôpital de la Cavale Blanche /ID# 271114
Brest, Brittany Region, France, 29200
Actively Recruiting
45
CHU Toulouse - Hôpital Rangueil /ID# 271138
Toulouse, Occitanie, France, 31400
Actively Recruiting
46
Hopital de la Conception /ID# 271152
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
Actively Recruiting
47
Hopital Universitaire Necker Enfants Malades /ID# 271146
Paris, Île-de-France Region, France, 75015
Actively Recruiting
48
TUM Klinikum rechts der Isar /ID# 271522
Munich, Bavaria, Germany, 81675
Actively Recruiting
49
Medizinische Hochschule Hannover /ID# 270938
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
50
Universitaetsklinikum Koeln /ID# 270937
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
51
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935
Berlin, Germany, 10117
Actively Recruiting
52
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563
Rome, Roma, Italy, 00161
Actively Recruiting
53
Hokkaido University Hospital /ID# 271385
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
54
National Hospital Organization Kyoto Medical Center /ID# 271782
Kyoto, Kyoto, Japan, 612-8555
Actively Recruiting
55
Juntendo University Hospital /ID# 271722
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
56
National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 272022
Chiba, Japan, 260-8712
Actively Recruiting
57
Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247
Dordrecht, South Holland, Netherlands, 3318 AT
Actively Recruiting
58
Lumc /Id# 271844
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
59
Universitair Medisch Centrum Groningen /ID# 271249
Groningen, Netherlands, 9713 GR
Actively Recruiting
60
Unidade Local de Saude de Almada-Seixal, EPE /ID# 271257
Almada, Setúbal District, Portugal, 2805-267
Actively Recruiting
61
2CA-Braga, Hospital de Braga /ID# 271258
Braga, Portugal, 4710-243
Actively Recruiting
62
Unidade Local de Saude do Algarve, EPE /ID# 271819
Faro, Portugal, 8000-386
Actively Recruiting
63
Unidade Local de Saude de Sao Jose, EPE /ID# 271255
Lisbon, Portugal, 1150-199
Actively Recruiting
64
Unidade Local de Saude de Lisboa Ocidental, EPE /ID# 271261
Lisbon, Portugal, 1449-005
Actively Recruiting
65
Pusan National University Hospital /ID# 271429
Busan, Busan Gwang Yeogsi, South Korea, 49241
Actively Recruiting
66
Keimyung University Dongsan Hospital /ID# 272455
Daegu, Gyeongsangbuk-do, South Korea, 42601
Actively Recruiting
67
Seoul National University Hospital /ID# 271331
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
68
SMG-SNU Boramae Medical Center /ID# 271227
Seoul, Seoul Teugbyeolsi, South Korea, 07061
Actively Recruiting
69
Hallym University Kangnam Sacred Heart Hospital /ID# 271329
Seoul, Seoul Teugbyeolsi, South Korea, 07441
Actively Recruiting
70
Hospital Universitari de Bellvitge /ID# 270489
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
71
Fundacio Puigvert /ID# 270491
Barcelona, Spain, 08025
Actively Recruiting
72
Hospital Universitario Virgen de las Nieves /ID# 270918
Granada, Spain, 18014
Actively Recruiting
73
Hospital Universitario Fundacion Jimenez Diaz /ID# 270485
Madrid, Spain, 28040
Actively Recruiting
74
Hospital Universitario 12 de Octubre /ID# 270829
Madrid, Spain, 28041
Actively Recruiting
75
Hospital Clínico Universitario de Valencia /ID# 270837
Valencia, Spain, 46010
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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