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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, California 92844

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

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

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

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

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

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

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

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

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

Panax Clinical Research /ID# 270851
Miami, Florida 33014

Infigo Clinical Research /ID# 270844
Sanford, Florida 32771

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

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

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

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

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

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

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

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

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

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

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

Washington University /ID# 271436
St Louis, Missouri 63110

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

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

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

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

University of Pennsylvania /ID# 270301
Philadelphia, Pennsylvania 19104

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

Knoxville Kidney Center /ID# 270706
Knoxville, Tennessee 37923

Arlington Nephrology /ID# 270494
Arlington, Texas 76015

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

University of Virginia /ID# 270329
Charlottesville, Virginia 22908

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

More Details

Status
Recruiting
Sponsor
Calico Life Sciences LLC

Study Contact

Calico Clinical Trial Communication
650-754-6200
clinicaltrialcommunication@calicolabs.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.