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)
Purpose
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.
Condition
- Autosomal Dominant Polycystic Kidney Disease
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications. - Any exclusionary medical diseases, disorders, or conditions as described in the protocol.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
National Institute of Clinical Research - Garden Grove /ID# 271418
Garden Grove 5351515, California 5332921 92844
Garden Grove 5351515, California 5332921 92844
Contact:
Site Coordinator
(909) 206-2454
Site Coordinator
(909) 206-2454
Valiance Clinical Research - Huntington Park /ID# 270634
Huntington Park 5358736, California 5332921 90255
Huntington Park 5358736, California 5332921 90255
Academic Medical Research Institute - Los Angeles /ID# 270502
Los Angeles 5368361, California 5332921 90022
Los Angeles 5368361, California 5332921 90022
UC Irvine Medical Center /ID# 270811
Orange 5379513, California 5332921 92868-3201
Orange 5379513, California 5332921 92868-3201
University Of California, San Francisco /ID# 270326
San Francisco 5391959, California 5332921 94143-2202
San Francisco 5391959, California 5332921 94143-2202
Yale University School of Medicine /ID# 270675
New Haven 4839366, Connecticut 4831725 06510
New Haven 4839366, Connecticut 4831725 06510
Horizon Research Group - Coral Gables /ID# 270857
Coral Gables 4151871, Florida 4155751 33134
Coral Gables 4151871, Florida 4155751 33134
South Florida Research Institute /ID# 270848
Fort Lauderdale 4155966, Florida 4155751 33313
Fort Lauderdale 4155966, Florida 4155751 33313
Nature Coast Clinical Research - Inverness /ID# 270875
Inverness 4159786, Florida 4155751 34452-4717
Inverness 4159786, Florida 4155751 34452-4717
Mayo Clinic Hospital Jacksonville /ID# 271011
Jacksonville 4160021, Florida 4155751 32224
Jacksonville 4160021, Florida 4155751 32224
Panax Clinical Research /ID# 270851
Miami 4164138, Florida 4155751 33014
Miami 4164138, Florida 4155751 33014
Infigo Clinical Research /ID# 270844
Sanford 4172086, Florida 4155751 32771
Sanford 4172086, Florida 4155751 32771
Emory University School Of Medicine - Atlanta /ID# 271947
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
CARE-Boise Kidney /ID# 270628
Boise 5586437, Idaho 5596512 83706
Boise 5586437, Idaho 5596512 83706
CARE Institute - Idaho Falls /ID# 272005
Idaho Falls 5596475, Idaho 5596512 83404
Idaho Falls 5596475, Idaho 5596512 83404
Northwestern University Feinberg School of Medicine /ID# 271409
Chicago 4887398, Illinois 4896861 60611-2927
Chicago 4887398, Illinois 4896861 60611-2927
University of Iowa /ID# 270492
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
University of Kansas Medical Center /ID# 271946
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Tufts Medical Center /ID# 270323
Boston 4930956, Massachusetts 6254926 02111-1552
Boston 4930956, Massachusetts 6254926 02111-1552
Beth Israel Deaconess Medical Center /ID# 271408
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
University Of Michigan /ID# 270436
Ann Arbor 4984247, Michigan 5001836 48109-5000
Ann Arbor 4984247, Michigan 5001836 48109-5000
St. Clair Nephrology /ID# 271445
Shelby 5009586, Michigan 5001836 48315
Shelby 5009586, Michigan 5001836 48315
Mayo Clinic Hospital Rochester /ID# 270428
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Washington University /ID# 271436
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
Icahn School of Medicine at Mount Sinai /ID# 271440
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
University of North Carolina at Chapel Hill /ID# 274800
Chapel Hill 4460162, North Carolina 4482348 27599-0001
Chapel Hill 4460162, North Carolina 4482348 27599-0001
Brookview Hills Research Associates /ID# 271449
Winston-Salem 4499612, North Carolina 4482348 27103
Winston-Salem 4499612, North Carolina 4482348 27103
Northeast Clinical Research Center /ID# 270838
Bethlehem 5180225, Pennsylvania 6254927 18017
Bethlehem 5180225, Pennsylvania 6254927 18017
University of Pennsylvania /ID# 270301
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Nephrology Associates - Chattanooga - East Third Street /ID# 270701
Chattanooga 4612862, Tennessee 4662168 37404
Chattanooga 4612862, Tennessee 4662168 37404
Knoxville Kidney Center /ID# 270706
Knoxville 4634946, Tennessee 4662168 37923
Knoxville 4634946, Tennessee 4662168 37923
Arlington Nephrology /ID# 270494
Arlington 4671240, Texas 4736286 76015
Arlington 4671240, Texas 4736286 76015
Renal Disease Research Institute /ID# 270339
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
University of Virginia /ID# 270329
Charlottesville 4752031, Virginia 6254928 22908
Charlottesville 4752031, Virginia 6254928 22908
Swedish Medical Center - Seattle /ID# 270344
Seattle 5809844, Washington 5815135 98104
Seattle 5809844, Washington 5815135 98104
More Details
- Status
- Recruiting
- Sponsor
- AbbVie