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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

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

ArmDescriptionAssigned Intervention
Experimental
ABBV-CLS-628 Dose A 		Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
  • Drug: ABBV-CLS-628
    IntraVenous Infusion
Experimental
ABBV-CLS-628 Dose B 		Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
  • Drug: ABBV-CLS-628
    IntraVenous Infusion
Experimental
ABBV-CLS-628 Dose C 		Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
  • Drug: ABBV-CLS-628
    IntraVenous Infusion
Placebo Comparator
Placebo 		Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
  • Drug: Placebo
    IntraVenous Infusion

Recruiting Locations

National Institute of Clinical Research - Garden Grove /ID# 271418
Garden Grove 5351515, California 5332921 92844
Contact:
Site Coordinator
(909) 206-2454

Valiance Clinical Research - Huntington Park /ID# 270634
Huntington Park 5358736, California 5332921 90255

Academic Medical Research Institute - Los Angeles /ID# 270502
Los Angeles 5368361, California 5332921 90022

UC Irvine Medical Center /ID# 270811
Orange 5379513, California 5332921 92868-3201

University Of California, San Francisco /ID# 270326
San Francisco 5391959, California 5332921 94143-2202

Yale University School of Medicine /ID# 270675
New Haven 4839366, Connecticut 4831725 06510

Horizon Research Group - Coral Gables /ID# 270857
Coral Gables 4151871, Florida 4155751 33134

South Florida Research Institute /ID# 270848
Fort Lauderdale 4155966, Florida 4155751 33313

Nature Coast Clinical Research - Inverness /ID# 270875
Inverness 4159786, Florida 4155751 34452-4717

Mayo Clinic Hospital Jacksonville /ID# 271011
Jacksonville 4160021, Florida 4155751 32224

Panax Clinical Research /ID# 270851
Miami 4164138, Florida 4155751 33014

Infigo Clinical Research /ID# 270844
Sanford 4172086, Florida 4155751 32771

Emory University School Of Medicine - Atlanta /ID# 271947
Atlanta 4180439, Georgia 4197000 30322

CARE-Boise Kidney /ID# 270628
Boise 5586437, Idaho 5596512 83706

CARE Institute - Idaho Falls /ID# 272005
Idaho Falls 5596475, Idaho 5596512 83404

Northwestern University Feinberg School of Medicine /ID# 271409
Chicago 4887398, Illinois 4896861 60611-2927

University of Iowa /ID# 270492
Iowa City 4862034, Iowa 4862182 52242

University of Kansas Medical Center /ID# 271946
Kansas City 4273837, Kansas 4273857 66160

Tufts Medical Center /ID# 270323
Boston 4930956, Massachusetts 6254926 02111-1552

Beth Israel Deaconess Medical Center /ID# 271408
Boston 4930956, Massachusetts 6254926 02215

University Of Michigan /ID# 270436
Ann Arbor 4984247, Michigan 5001836 48109-5000

St. Clair Nephrology /ID# 271445
Shelby 5009586, Michigan 5001836 48315

Mayo Clinic Hospital Rochester /ID# 270428
Rochester 5043473, Minnesota 5037779 55905

Washington University /ID# 271436
St Louis 4407066, Missouri 4398678 63110

Icahn School of Medicine at Mount Sinai /ID# 271440
New York 5128581, New York 5128638 10029

University of North Carolina at Chapel Hill /ID# 274800
Chapel Hill 4460162, North Carolina 4482348 27599-0001

Brookview Hills Research Associates /ID# 271449
Winston-Salem 4499612, North Carolina 4482348 27103

Northeast Clinical Research Center /ID# 270838
Bethlehem 5180225, Pennsylvania 6254927 18017

University of Pennsylvania /ID# 270301
Philadelphia 4560349, Pennsylvania 6254927 19104

Nephrology Associates - Chattanooga - East Third Street /ID# 270701
Chattanooga 4612862, Tennessee 4662168 37404

Knoxville Kidney Center /ID# 270706
Knoxville 4634946, Tennessee 4662168 37923

Arlington Nephrology /ID# 270494
Arlington 4671240, Texas 4736286 76015

Renal Disease Research Institute /ID# 270339
Fort Worth 4691930, Texas 4736286 76104

University of Virginia /ID# 270329
Charlottesville 4752031, Virginia 6254928 22908

Swedish Medical Center - Seattle /ID# 270344
Seattle 5809844, Washington 5815135 98104

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.