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NCT06902558RecruitingPhase 2

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, 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)

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
240 (estimated)
First submitted
25 Mar 2025
Start date
9 Jun 2025
Primary completion date
Aug 2029
Lead sponsor
Calico Life Sciences LLC
NCT number
NCT06902558
EU CT number
2024-517143-31-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 240
  • From 9 Jun 2025 to the primary completion date, Aug 2029
  • 91 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.

Other illness

  • Any exclusionary medical diseases, disorders, or conditions as described in the protocol.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (91)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaRecruiting
Royal Brisbane and Women's Hospital
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BrisbaneAustraliaRecruiting
Fiona Stanley Hospital
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MurdochAustraliaRecruiting
Westmead Hospital
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WestmeadAustraliaRecruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Lakeridge Health Corporation-Oshawa
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OshawaCanadaNot yet recruiting
St. Michael's Hospital
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TorontoCanadaNot yet recruiting
Toronto General Hospital, University Health Network
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TorontoCanadaNot yet recruiting
Humber River Hospital
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TorontoCanadaNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
University Hospital Cologne AöR
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CologneGermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyActive, not recruiting
Fundació Puigvert
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BarcelonaSpainActive, not recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainActive, not recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceActive, not recruiting
Hospices Civils De Lyon
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Lyon Cedex 03FranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
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BariItalyActive, not recruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyActive, not recruiting
Juntendo University Hospital
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Bunkyo-kuJapanRecruiting
National Hospital Org Chiba Medical Center Chibahigashi National Hospital
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ChibaJapanRecruiting
National Hospital Organization Kyoto Medical Center
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KyotoJapanRecruiting
Hokkaido University Hospital
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SapporoJapanRecruiting
Pusan National University Hospital
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BusanSouth KoreaRecruiting
Keimyung University Dongsan Hospital
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DaeguSouth KoreaRecruiting
Hallym University Kangnam Sacred Heart Hospital
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
SMG-SNU Boramae Medical Center
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SeoulSouth KoreaActive, not recruiting
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
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AlmadaPortugalActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalActive, not recruiting
Unidade Local De Saúde De Lisboa Ocidental E.P.E.
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CarnaxidePortugalActive, not recruiting
Unidade Local de Saude do Algarve E.P.E.
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FaroPortugalActive, not recruiting
Servico de Saude da Regiao Autonoma Da Madeira EPERAM
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FunchalPortugalActive, not recruiting
Unidade Local De Saude De Sao Jose E.P.E.
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LisbonPortugalActive, not recruiting
University of Michigan
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Ann ArborUnited StatesRecruiting
Arlington Nephrology
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ArlingtonUnited StatesWithdrawn
Emory University School Of Medicine - Atlanta
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AtlantaUnited StatesRecruiting
Northeast Clinical Research Center
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BethlehemUnited StatesRecruiting
University of Alabama at Birmingham
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BirminghamUnited StatesRecruiting
CARE-Boise Kidney
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BoiseUnited StatesRecruiting
Beth Israel Deaconess Medical Center
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BostonUnited StatesRecruiting
Tufts Medical Center
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BostonUnited StatesRecruiting
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesNot yet recruiting
Nephrology Associates - Chattanooga - East Third Street
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ChattanoogaUnited StatesRecruiting
Northwestern University Feinberg School of Medicine
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ChicagoUnited StatesRecruiting
Horizon Research Group - Coral Gables
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Coral GablesUnited StatesWithdrawn
Renal Disease Research Institute
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DallasUnited StatesRecruiting
South Florida Research Institute
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Fort LauderdaleUnited StatesRecruiting
Valiance Clinical Research: Huntington Park
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Huntington ParkUnited StatesRecruiting
Care Institute - Idaho Falls
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Idaho FallsUnited StatesRecruiting
Nature Coast Clinical Research - Inverness
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InvernessUnited StatesRecruiting
University of Iowa
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Iowa CityUnited StatesRecruiting
Mayo Clinic Hospital - Jacksonville
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JacksonvilleUnited StatesRecruiting
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
Knoxville Kidney Center
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KnoxvilleUnited StatesRecruiting
Academic Medical Research Institute (AMRI) - Los Angeles
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Los AngelesUnited StatesRecruiting
Panax Clinical Research
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MiamiUnited StatesRecruiting
University of Miami Don Suffer Clinical Research Building
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MiamiUnited StatesRecruiting
The Vanderbilt University Medical Center (VUMC)
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NashvilleUnited StatesNot yet recruiting
Yale University School Of Medicine
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New HavenUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesRecruiting
Rogosin Institute
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New YorkUnited StatesNot yet recruiting
UC Irvine Medical Center
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OrangeUnited StatesRecruiting
University of Pennsylvania
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PhiladelphiaUnited StatesRecruiting
National Institute of Clinical Research - Pomona
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PomonaUnited StatesRecruiting
Mayo Clinic Hospital - Rochester
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RochesterUnited StatesRecruiting
Infigo Clinical Research
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SanfordUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
University of California Los Angeles Medical Center
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Santa MonicaUnited StatesNot yet recruiting
Swedish Medical Center_Seattle
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SeattleUnited StatesRecruiting
St. Clair Nephrology
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ShelbyUnited StatesRecruiting
Washington University School of Medicine - St. Louis
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St LouisUnited StatesRecruiting
Brookview Hills Research Associates
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Winston-SalemUnited StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.