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Autosomal Dominant Polycystic Kidney DiseasePhase 2ANCHORNCT06902558

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

A Phase 2 study testing ABBV-CLS-628 in people with Autosomal Dominant Polycystic Kidney Disease, run by Calico Life Sciences LLC at 91 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
ABBV-CLS-628
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
91 sitesin 12 countries
Study dates
9 Jun 2025to Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

91 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Calico Clinical Trial Communication contact

650-754-6200

clinicaltrialcommunication@calicolabs.com

91 sites in 12 countries

United States40 sites, 38 recruiting

  • University Of Michigan

    Ann Arbor, Michigan, 48109-5000

    Michael Heung, MD, 734-936-6489, mheung@umich.edu

    Recruiting

  • Arlington Nephrology

    Arlington, Texas, 76015

    Withdrawn

  • Emory University School Of Medicine - Atlanta

    Atlanta, Georgia, 30322

    Frederic Rahbari Oskoui, 404-727-2590, frahbar@emory.edu

    Recruiting

  • Northeast Clinical Research Center

    Bethlehem, Pennsylvania, 18017

    Stephanie Hanzl, RN, 610-433-4100 ext. 490, steph.hanzl@necresearch.org

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Maria El Hachem, 205-975-0549, mehachem@uabmc.edu

    Recruiting

  • CARE-Boise Kidney

    Boise, Idaho, 83706

    Samantha Stinemetz, 208-996-1944, Samantha@CardioRenalInstitute.com

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111-1552

    Olaniyi Ogunbodede, 617-636-5076, olaniyi.ogunbodede@tuftsmedicine.org

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Peter Czarnecki, MD, 617-632-9890, nephrologyadminsupport@bidmc.harvard.edu

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-0001

    Emily Chang, MD, 919-445-2621, emily_chang@med.unc.edu

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Not yet recruiting

  • Nephrology Associates - Chattanooga - East Third Street

    Chattanooga, Tennessee, 37404

    Southeast Renal Research Institute, 423-826-8003, research@nephassociates.com

    Recruiting

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611-2927

    Patrick Fox, 312-503-1887, patrick.fox@northwestern.edu

    Recruiting

  • Horizon Research Group - Coral Gables

    Coral Gables, Florida, 33134

    Withdrawn

  • Renal Disease Research Institute

    Dallas, Texas, 75204

    Caren Swift, 214-366-6094, swiftc@DNEPH.com

    Recruiting

  • South Florida Research Institute

    Fort Lauderdale, Florida, 33313

    Marie Pierre Louis, 954-739-4474, marie.pierrelouis@sfriresearch.com

    Recruiting

  • Valiance Clinical Research - Huntington Park

    Huntington Park, California, 90255

    Josh Lai, 323-484-0508, j.lai@ValianceClinicalResearch.com

    Recruiting

  • CARE Institute - Idaho Falls

    Idaho Falls, Idaho, 83404

    Carolina Saldana, 208-984-2273, Carolina@cardiorenalinstitute.com

    Recruiting

  • Nature Coast Clinical Research - Inverness

    Inverness, Florida, 34452-4717

    Rafik Abadier, 352-341-2100, rabadier@flourishresearch.com

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Jissele Verdinez, 319-384-5369, jissele-verdinez@uiowa.edu

    Recruiting

  • Mayo Clinic Hospital Jacksonville

    Jacksonville, Florida, 32224

    Mia Schell, 904-953-3671, schell.mia@mayo.edu

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Jordan Elliott, jelliott11@kumc.edu

    Recruiting

  • Knoxville Kidney Center

    Knoxville, Tennessee, 37923

    Tammy Conger, 865-692-3462, tconger@knoxvillekidneycenter.com

    Recruiting

  • Academic Medical Research Institute (AMRI) - Los Angeles

    Los Angeles, California, 90022

    Mohamed Shahawy, MD, MPH, 323-725-0051, md@amrionline.net

    Recruiting

  • Panax Clinical Research

    Miami, Florida, 33014

    Robert G. Perry, MD, 305-698-4500, rperry@panaxcr.com

    Recruiting

  • University of Miami Don Suffer Clinical Research Building

    Miami, Florida, 33136

    Carlos Bidot, 305-243-8793, cbidot2@med.miami.edu

    Recruiting

  • The Vanderbilt University Medical Center (VUMC)

    Nashville, Tennessee, 37212

    Not yet recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

    Jessica Li, 203-737-1091, jessica.a.li@yale.edu

    Romani Osbourne, 203-737-1091, romani.osbourne@yale.edu

    Recruiting

  • Rogosin Institute

    New York, New York, 10021

    Not yet recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Icahn School of Medicine Mount Sinai, 212-241-2339

    Recruiting

  • UC Irvine Medical Center

    Orange, California, 92868-3201

    Ahmad Walid Roshan, 714-509-6271, ahmadwar@hs.uci.edu

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Krishna Kallem, krishna.kallem@pennmedicine.upenn.edu

    Simin Goral, MD, simin.goral@pennmedicine.upenn.edu

    Recruiting

  • National Institute of Clinical Research - Pomona

    Pomona, California, 91768

    National Institute of Clinical Research, Inc., 323-725-0657, nicr@nicresearch.com

    Recruiting

  • Mayo Clinic Hospital - Rochester

    Rochester, Minnesota, 55905

    Ryan Helland, 507-422-3998, Helland.Ryan@mayo.edu

    Recruiting

  • University Of California, San Francisco

    San Francisco, California, 94143-2202

    Meyeon Park, MD, 415-514-1122, PKD@ucsf.edu

    Recruiting

  • Infigo Clinical Research

    Sanford, Florida, 32771

    Leianna Lewis, info@infigoresearch.com

    Recruiting

  • University of California Los Angeles Medical Center

    Santa Monica, California, 90404

    Not yet recruiting

  • Swedish Medical Center - Seattle

    Seattle, Washington, 98104

    Adel Islam, 206-215-6532, adel.islam@swedish.org

    Recruiting

  • St. Clair Nephrology

    Shelby, Michigan, 48315

    Rosemarie Henschel, RN, 313-432-6273, rhenschel@scsp.net

    Recruiting

  • Washington University School of Medicine - St Louis

    St Louis, Missouri, 63110

    Seth Goldberg, MD, 314-362-9096, sgoldber@wustl.edu

    Recruiting

  • Brookview Hills Research Associates

    Winston-Salem, North Carolina, 27103

    Janice Rogers, 336-245-6330, jrogers@brookviewhills.com

    Recruiting

Other trials in United States

Spain7 sites, 7 recruiting

  • Fundacio Puigvert

    Barcelona, Barcelona, 08025

    Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada, 18014

    Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, Sevilla, 41013

    Not yet recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

    Recruiting

Other trials in Spain

Portugal6 sites, 6 recruiting

  • Unidade Local de Saude de Almada-Seixal, EPE

    Almada, Setúbal District, 2805-267

    Recruiting

  • 2CA-Braga, Hospital de Braga

    Braga, Braga District, 4710-243

    Recruiting

  • Unidade Local de Saude do Algarve, EPE

    Faro, Faro District, 8000-386

    Recruiting

  • Centro Hospitalar Do Funchal

    Funchal, 9000-168

    Not yet recruiting

  • Hospital Curry Cabral

    Lisbon, Lisbon District, 1069-166

    Recruiting

  • Unidade Local de Saude de Lisboa Ocidental, EPE

    Lisbon, Lisbon District, 2799-523

    Recruiting

Other trials in Portugal

France5 sites, 5 recruiting

  • CHU Brest - Hôpital de la Cavale Blanche

    Brest, Brittany Region, 29200

    Recruiting

  • Hopital Edouard Herriot

    Lyon, Auvergne-Rhône-Alpes, 69003

    Recruiting

  • Hopital de la Conception

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005

    Recruiting

  • Hopital Universitaire Necker Enfants Malades

    Paris, Île-de-France Region, 75015

    Recruiting

  • CHU Toulouse - Hôpital Rangueil

    Toulouse, Occitanie, 31400

    Recruiting

Other trials in France

Germany5 sites, 5 recruiting

  • Charite Universitaetsmedizin Berlin - Campus Mitte

    Berlin, State of Berlin, 10117

    Recruiting

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

    Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Not yet recruiting

  • TUM Klinikum rechts der Isar

    Munich, Bavaria, 81675

    Recruiting

Other trials in Germany

South Korea5 sites, 4 recruiting

  • Pusan National University Hospital

    Busan, Busan Gwang Yeogsi, 49241

    Jung Yoon Moon, +82 10-6619-7204, jeungy0520@naver.com

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, Gyeongsangbuk-do, 42601

    Yaerim Kim, MD, +82 53-258-4740, yaerim86@dsmc.or.kr

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Yong Chul Kim, MD, imyongkim@gmail.com

    Recruiting

  • SMG-SNU Boramae Medical Center

    Seoul, Seoul Teugbyeolsi, 07061

    Active, not recruiting

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, Seoul Teugbyeolsi, 07441

    Hayne Park, MD, haynepark798@hallym.or.kr

    Recruiting

Other trials in South Korea

Australia4 sites, 4 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Professor Randall Faull, +61 04238 43430, Health.RAHCNARTSClinicalTrials@sa.gov.au

    Recruiting

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

    Martin Wolley, MD, +61 07 36468576, martin.wolley@health.qld.gov.au

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

    Ashley Irish, MD, +61 08 6152 2222, Ashley.irish@health.wa.gov.au

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Gopi Rangan, MD, gopi.rangan@health.nsw.gov.au

    Recruiting

Other trials in Australia

Canada4 sites, 4 recruiting

  • Lakeridge Health Corporation-Oshawa

    Oshawa, Ontario, L1H 2B9

    Not yet recruiting

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

    Not yet recruiting

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Not yet recruiting

  • Toronto General Hospital-University Health Network

    Toronto, Ontario, M5G 2C4

    Not yet recruiting

Other trials in Canada

Italy4 sites, 4 recruiting

  • A.O.U. Consorziale Policlinico di Bari

    Bari, Metropolitan City of Bari, 70124

    Not yet recruiting

  • AOU di Modena - Ospedale di Modena

    Modena, Modena, 41124

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    Rome, Roma, 00161

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica

    Rome, Roma, 00168

    Not yet recruiting

Other trials in Italy

Japan4 sites, 4 recruiting

  • Juntendo University Hospital

    Bunkyō-Ku, Tokyo, 113-8431

    Recruiting

  • National Hospital Org Chiba Medical Center Chibahigashi National Hospital

    Chiba, Chiba, 260-8712

    Recruiting

  • National Hospital Organization Kyoto Medical Center

    Kyoto, Kyoto, 612-8555

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Recruiting

Other trials in Japan

Netherlands4 sites, 3 recruiting

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk

    Dordrecht, South Holland, 3318 AT

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, Provincie Groningen, 9713 GR

    Withdrawn

  • LUMC

    Leiden, South Holland, 2333 ZA

    Recruiting

  • Erasmus Medisch Centrum

    Rotterdam, South Holland, 3015 AA

    Not yet recruiting

Other trials in Netherlands

Belgium3 sites, 3 recruiting

  • Cliniques Universitaires UCL Saint-Luc

    Brussels, Brussels Capital, 1200

    Recruiting

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

    Recruiting

  • CHU de Liege

    Liège, Liège, 4000

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Read more

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.

Being tested
ABBV-CLS-628, Placebo
Keywords
Autosomal Dominant Polycystic Kidney Disease (ADPKD), ABBV-CLS-628
Medical subject headings
Polycystic Kidney, Autosomal Dominant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-CLS-628Drug

    IntraVenous Infusion

  • PlaceboDrug

    IntraVenous Infusion

Study groups in NCT06902558
Study groupRoleWhat they receive
ABBV-CLS-628 Dose AExperimentalParticipants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
Receives: Drug: ABBV-CLS-628
ABBV-CLS-628 Dose BExperimentalParticipants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
Receives: Drug: ABBV-CLS-628
ABBV-CLS-628 Dose CExperimentalParticipants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
Receives: Drug: ABBV-CLS-628
PlaceboPlacebo comparatorParticipants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)

    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).

    Measured: Week 96

  2. Number of Participants with Adverse Events (AEs)

    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.

    Measured: Up to approximately 118 weeks

Secondary outcomes (4)

  1. Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline

    eGFR will be measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).

    Measured: Week 96

  2. Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)

    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).

    Measured: Week 48

  3. Absolute Change in eGFR From Baseline

    eGFR will be measured using the CKD-EPI Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).

    Measured: Week 48

  4. Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR

    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.

    Measured: Up to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start9 Jun 2025
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06902558
Sponsor's protocol ID
M25-147
Other IDs
2024-517143-31-00
Acronym
ANCHOR
Status last verified
Oct 2026
First submitted
25 Mar 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12.

    PubMed 41385299

  • Cortinovis M, Perico N, Remuzzi G. The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care. Clin J Am Soc Nephrol. 2025 Dec 5. doi: 10.2215/CJN.0000000975. Online ahead of print.

    PubMed 41348481

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-CLS-628 in people with Autosomal Dominant Polycystic Kidney Disease, run by Calico Life Sciences LLC at 91 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Spain, Portugal, France, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Calico Clinical Trial Communication (650-754-6200, clinicaltrialcommunication@calicolabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) (time frame: Week 96). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06902558, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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