ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (ANCHOR)

August 3, 2026 updated by: Calico Life Sciences LLC

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
          • Gopi Rangan, MD
          • Phone Number: gopi.rangan@health.nsw.gov.au
    • Queensland
      • Brisbane, Queensland, Australia, 4029
    • South Australia
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Ucl Saint-Luc
    • Liège
      • Liège, Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1H 2B9
        • Not yet recruiting
        • Lakeridge Health Corporation-Oshawa
      • Toronto, Ontario, Canada, M5B 1W8
        • Not yet recruiting
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M3M 0B2
        • Not yet recruiting
        • Humber River Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Not yet recruiting
        • Toronto General Hospital-University Health Network
  • France
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69003
        • Recruiting
        • Hôpital Edouard Herriot
    • Brittany Region
      • Brest, Brittany Region, France, 29200
        • Recruiting
        • CHU Brest - Hôpital de la Cavale Blanche
    • Occitanie
      • Toulouse, Occitanie, France, 31400
        • Recruiting
        • CHU Toulouse - Hopital Rangueil
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
        • Recruiting
        • Hôpital de La Conception
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades
  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Not yet recruiting
        • Universitaetsklinikum Heidelberg
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • TUM Klinikum rechts der Isar
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10117
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte
  • Italy
    • Metropolitan City of Bari
      • Bari, Metropolitan City of Bari, Italy, 70124
        • Not yet recruiting
        • A.O.U. Consorziale Policlinico di Bari
    • Modena
      • Modena, Modena, Italy, 41124
        • Not yet recruiting
        • AOU di Modena - Ospedale di Modena
    • Roma
      • Rome, Roma, Italy, 00161
        • Recruiting
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I
      • Rome, Roma, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica
  • Japan
    • Chiba
      • Chiba, Chiba, Japan, 260-8712
        • Recruiting
        • National Hospital Org Chiba Medical Center Chibahigashi National Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
    • Kyoto
      • Kyoto, Kyoto, Japan, 612-8555
        • Recruiting
        • National Hospital Organization Kyoto Medical Center
    • Tokyo
      • Bunkyō-Ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
  • Netherlands
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9713 GR
        • Withdrawn
        • Universitair Medisch Centrum Groningen
    • South Holland
      • Dordrecht, South Holland, Netherlands, 3318 AT
        • Recruiting
        • Albert Schweitzer Ziekenhuis, locatie Dordwijk
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Recruiting
        • LUMC
      • Rotterdam, South Holland, Netherlands, 3015 AA
        • Not yet recruiting
        • Erasmus Medisch Centrum
  • Portugal
      • Funchal, Portugal, 9000-168
        • Not yet recruiting
        • Centro Hospitalar Do Funchal
    • Braga District
      • Braga, Braga District, Portugal, 4710-243
        • Recruiting
        • 2CA-Braga, Hospital de Braga
    • Faro District
      • Faro, Faro District, Portugal, 8000-386
        • Recruiting
        • Unidade Local de Saude do Algarve, EPE
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1069-166
        • Recruiting
        • Hospital Curry Cabral
      • Lisbon, Lisbon District, Portugal, 2799-523
        • Recruiting
        • Unidade Local de Saude de Lisboa Ocidental, EPE
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Recruiting
        • Unidade Local de Saude de Almada-Seixal, EPE
  • South Korea
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Seoul Teugbyeolsi, South Korea, 07441
      • Seoul, Seoul Teugbyeolsi, South Korea, 07061
        • Active, not recruiting
        • SMG-SNU Boramae Medical Center
  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08025
        • Recruiting
        • Fundacio Puigvert
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
    • Granada
      • Granada, Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocío
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
    • California
      • Huntington Park, California, United States, 90255
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Academic Medical Research Institute (AMRI) - Los Angeles
        • Contact:
      • Orange, California, United States, 92868-3201
        • Recruiting
        • UC Irvine Medical Center
        • Contact:
      • Pomona, California, United States, 91768
        • Recruiting
        • National Institute of Clinical Research - Pomona
        • Contact:
          • National Institute of Clinical Research, Inc.
          • Phone Number: 323-725-0657
          • Email: nicr@nicresearch.com
      • San Francisco, California, United States, 94143-2202
        • Recruiting
        • University of California, San Francisco
        • Contact:
          • Meyeon Park, MD
          • Phone Number: 415-514-1122
          • Email: PKD@ucsf.edu
      • Santa Monica, California, United States, 90404
        • Not yet recruiting
        • University of California Los Angeles Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Withdrawn
        • Horizon Research Group - Coral Gables
      • Fort Lauderdale, Florida, United States, 33313
      • Inverness, Florida, United States, 34452-4717
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Hospital Jacksonville
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Don Suffer Clinical Research Building
        • Contact:
      • Miami, Florida, United States, 33014
        • Recruiting
        • Panax Clinical Research
        • Contact:
      • Sanford, Florida, United States, 32771
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School Of Medicine - Atlanta
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83706
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Recruiting
        • Northwestern University Feinberg School of Medicine
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
    • Massachusetts
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5000
        • Recruiting
        • University of Michigan
        • Contact:
      • Shelby, Michigan, United States, 48315
        • Recruiting
        • St. Clair Nephrology
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Hospital - Rochester
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine - St Louis
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • Icahn School of Medicine Mount Sinai
          • Phone Number: 212-241-2339
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-0001
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Brookview Hills Research Associates
        • Contact:
    • Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Medical University of South Carolina
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Nephrology Associates - Chattanooga - East Third Street
        • Contact:
      • Knoxville, Tennessee, United States, 37923
      • Nashville, Tennessee, United States, 37212
        • Not yet recruiting
        • The Vanderbilt University Medical Center (VUMC)
    • Texas
      • Arlington, Texas, United States, 76015
        • Withdrawn
        • Arlington Nephrology
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Renal Disease Research Institute
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Medical Center - Seattle
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
Time Frame: Week 96
TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Week 96
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 118 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to approximately 118 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
Time Frame: Week 96
eGFR will be measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).
Week 96
Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
Time Frame: Week 48
TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Week 48
Absolute Change in eGFR From Baseline
Time Frame: Week 48
eGFR will be measured using the CKD-EPI Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).
Week 48
Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR
Time Frame: Up to Week 96
Defined as initiation of renal replacement therapy (RRT) or kidney transplantation, or a confirmed decline in eGFR of 40% or more from baseline, sustained for at least 4 weeks.
Up to Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calico Life Sciences LLC

Collaborators

Calico Life Sciences LLC

Investigators

  • Study Director: Study Director, Calico Life Sciences LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-147
  • 2024-517143-31-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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