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En undersøgelse til vurdering af bivirkninger og effektivitet af intravenøse infusioner af ABBV-CLS-628 hos voksne deltagere med autosomal dominerende polycystisk nyresygdom (ADPKD) (ANCHOR)

2. oktober 2026 opdateret af: Calico Life Sciences LLC

En fase 2, multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at evaluere sikkerheden og effektiviteten af ​​ABBV-CLS-628 hos voksne personer med autosomal dominerende polycystisk nyresygdom (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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

240

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
    • New South Wales
      • Westmead, New South Wales, Australien, 2145
        • Rekruttering
        • Westmead Hospital
        • Kontakt:
          • Gopi Rangan, MD
          • Telefonnummer: gopi.rangan@health.nsw.gov.au
    • Queensland
      • Brisbane, Queensland, Australien, 4029
    • South Australia
    • Western Australia
      • Murdoch, Western Australia, Australien, 6150
  • Belgien
    • Brussels Capital
      • Brussels, Brussels Capital, Belgien, 1200
        • Rekruttering
        • Cliniques Universitaires UCL Saint-Luc
    • Liège
      • Liège, Liège, Belgien, 4000
        • Rekruttering
        • CHU de Liege
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgien, 3000
        • Rekruttering
        • UZ Leuven
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1H 2B9
        • Ikke rekrutterer endnu
        • Lakeridge Health Corporation-Oshawa
      • Toronto, Ontario, Canada, M5B 1W8
        • Ikke rekrutterer endnu
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M3M 0B2
        • Ikke rekrutterer endnu
        • Humber River Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Ikke rekrutterer endnu
        • Toronto General Hospital-University Health Network
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Rekruttering
        • University of Alabama at Birmingham
        • Kontakt:
    • California
      • Huntington Park, California, Forenede Stater, 90255
      • Los Angeles, California, Forenede Stater, 90022
        • Rekruttering
        • Academic Medical Research Institute (AMRI) - Los Angeles
        • Kontakt:
      • Orange, California, Forenede Stater, 92868-3201
        • Rekruttering
        • UC Irvine Medical Center
        • Kontakt:
      • Pomona, California, Forenede Stater, 91768
        • Rekruttering
        • National Institute of Clinical Research - Pomona
        • Kontakt:
          • National Institute of Clinical Research, Inc.
          • Telefonnummer: 323-725-0657
          • E-mail: nicr@nicresearch.com
      • San Francisco, California, Forenede Stater, 94143-2202
        • Rekruttering
        • University Of California, San Francisco
        • Kontakt:
          • Meyeon Park, MD
          • Telefonnummer: 415-514-1122
          • E-mail: PKD@ucsf.edu
      • Santa Monica, California, Forenede Stater, 90404
        • Ikke rekrutterer endnu
        • University of California Los Angeles Medical Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33134
        • Trukket tilbage
        • Horizon Research Group - Coral Gables
      • Fort Lauderdale, Florida, Forenede Stater, 33313
      • Inverness, Florida, Forenede Stater, 34452-4717
        • Rekruttering
        • Nature Coast Clinical Research - Inverness
        • Kontakt:
      • Jacksonville, Florida, Forenede Stater, 32224
        • Rekruttering
        • Mayo Clinic Hospital Jacksonville
        • Kontakt:
      • Miami, Florida, Forenede Stater, 33136
        • Rekruttering
        • University of Miami Don Suffer Clinical Research Building
        • Kontakt:
      • Miami, Florida, Forenede Stater, 33014
        • Rekruttering
        • Panax Clinical Research
        • Kontakt:
      • Sanford, Florida, Forenede Stater, 32771
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Rekruttering
        • Emory University School Of Medicine - Atlanta
        • Kontakt:
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706
      • Idaho Falls, Idaho, Forenede Stater, 83404
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611-2927
        • Rekruttering
        • Northwestern University Feinberg School of Medicine
        • Kontakt:
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Rekruttering
        • University of Kansas Medical Center
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
      • Boston, Massachusetts, Forenede Stater, 02111-1552
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-5000
        • Rekruttering
        • University Of Michigan
        • Kontakt:
      • Shelby, Michigan, Forenede Stater, 48315
        • Rekruttering
        • St. Clair Nephrology
        • Kontakt:
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Rekruttering
        • Mayo Clinic Hospital - Rochester
        • Kontakt:
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Washington University School of Medicine - St Louis
        • Kontakt:
    • New York
      • New York, New York, Forenede Stater, 10029
        • Rekruttering
        • Icahn School of Medicine at Mount Sinai
        • Kontakt:
          • Icahn School of Medicine Mount Sinai
          • Telefonnummer: 212-241-2339
      • New York, New York, Forenede Stater, 10021
        • Ikke rekrutterer endnu
        • Rogosin Institute
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-0001
        • Rekruttering
        • University of North Carolina at Chapel Hill
        • Kontakt:
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Rekruttering
        • Brookview Hills Research Associates
        • Kontakt:
    • Pennsylvania
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Ikke rekrutterer endnu
        • Medical University of South Carolina
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Rekruttering
        • Nephrology Associates - Chattanooga - East Third Street
        • Kontakt:
      • Knoxville, Tennessee, Forenede Stater, 37923
      • Nashville, Tennessee, Forenede Stater, 37212
        • Ikke rekrutterer endnu
        • The Vanderbilt University Medical Center (VUMC)
    • Texas
      • Arlington, Texas, Forenede Stater, 76015
        • Trukket tilbage
        • Arlington Nephrology
      • Dallas, Texas, Forenede Stater, 75204
        • Rekruttering
        • Renal Disease Research Institute
        • Kontakt:
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Rekruttering
        • Swedish Medical Center - Seattle
        • Kontakt:
  • Frankrig
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, Frankrig, 69003
        • Rekruttering
        • Hopital Edouard Herriot
    • Brittany Region
      • Brest, Brittany Region, Frankrig, 29200
        • Rekruttering
        • CHU Brest - Hôpital de la Cavale Blanche
    • Occitanie
      • Toulouse, Occitanie, Frankrig, 31400
        • Rekruttering
        • CHU Toulouse - Hôpital Rangueil
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, Frankrig, 13005
        • Rekruttering
        • Hopital de la Conception
    • Île-de-France Region
      • Paris, Île-de-France Region, Frankrig, 75015
        • Rekruttering
        • Hopital Universitaire Necker Enfants Malades
  • Holland
    • Provincie Groningen
      • Groningen, Provincie Groningen, Holland, 9713 GR
        • Trukket tilbage
        • Universitair Medisch Centrum Groningen
    • South Holland
      • Dordrecht, South Holland, Holland, 3318 AT
        • Rekruttering
        • Albert Schweitzer Ziekenhuis, locatie Dordwijk
      • Leiden, South Holland, Holland, 2333 ZA
        • Rekruttering
        • LUMC
      • Rotterdam, South Holland, Holland, 3015 AA
        • Ikke rekrutterer endnu
        • Erasmus Medisch Centrum
  • Italien
    • Metropolitan City of Bari
      • Bari, Metropolitan City of Bari, Italien, 70124
        • Ikke rekrutterer endnu
        • A.O.U. Consorziale Policlinico di Bari
    • Modena
      • Modena, Modena, Italien, 41124
        • Ikke rekrutterer endnu
        • AOU di Modena - Ospedale di Modena
    • Roma
      • Rome, Roma, Italien, 00161
        • Rekruttering
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I
      • Rome, Roma, Italien, 00168
        • Ikke rekrutterer endnu
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica
  • Japan
    • Chiba
      • Chiba, Chiba, Japan, 260-8712
        • Rekruttering
        • National Hospital Org Chiba Medical Center Chibahigashi National Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Rekruttering
        • Hokkaido University Hospital
    • Kyoto
      • Kyoto, Kyoto, Japan, 612-8555
        • Rekruttering
        • National Hospital Organization Kyoto Medical Center
    • Tokyo
      • Bunkyō-Ku, Tokyo, Japan, 113-8431
        • Rekruttering
        • Juntendo University Hospital
  • Portugal
      • Funchal, Portugal, 9000-168
        • Ikke rekrutterer endnu
        • Centro Hospitalar Do Funchal
    • Braga District
      • Braga, Braga District, Portugal, 4710-243
        • Rekruttering
        • 2CA-Braga, Hospital de Braga
    • Faro District
      • Faro, Faro District, Portugal, 8000-386
        • Rekruttering
        • Unidade Local de Saude do Algarve, EPE
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1069-166
        • Rekruttering
        • Hospital Curry Cabral
      • Lisbon, Lisbon District, Portugal, 2799-523
        • Rekruttering
        • Unidade Local de Saude de Lisboa Ocidental, EPE
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Rekruttering
        • Unidade Local de Saude de Almada-Seixal, EPE
  • Spanien
    • Barcelona
      • Barcelona, Barcelona, Spanien, 08025
        • Rekruttering
        • Fundacio Puigvert
      • L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
        • Rekruttering
        • Hospital Universitari de Bellvitge
    • Granada
      • Granada, Granada, Spanien, 18014
        • Rekruttering
        • Hospital Universitario Virgen de las Nieves
    • Madrid
      • Madrid, Madrid, Spanien, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre
      • Madrid, Madrid, Spanien, 28040
        • Rekruttering
        • Hospital Universitario Fundacion Jimenez Diaz
    • Sevilla
      • Seville, Sevilla, Spanien, 41013
        • Ikke rekrutterer endnu
        • Hospital Universitario Virgen del Rocio
    • Valencia
      • Valencia, Valencia, Spanien, 46010
        • Rekruttering
        • Hospital Clínico Universitario de Valencia
  • Sydkorea
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, Sydkorea, 49241
        • Rekruttering
        • Pusan National University Hospital
        • Kontakt:
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, Sydkorea, 42601
        • Rekruttering
        • Keimyung University Dongsan Hospital
        • Kontakt:
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
        • Rekruttering
        • Seoul National University Hospital
        • Kontakt:
      • Seoul, Seoul Teugbyeolsi, Sydkorea, 07441
      • Seoul, Seoul Teugbyeolsi, Sydkorea, 07061
        • Aktiv, ikke rekrutterende
        • SMG-SNU Boramae Medical Center
  • Tyskland
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Tyskland, 69120
        • Ikke rekrutterer endnu
        • Universitaetsklinikum Heidelberg
    • Bavaria
      • Munich, Bavaria, Tyskland, 81675
        • Rekruttering
        • TUM Klinikum rechts der Isar
    • Lower Saxony
      • Hanover, Lower Saxony, Tyskland, 30625
        • Rekruttering
        • Medizinische Hochschule Hannover
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Tyskland, 50937
        • Rekruttering
        • Universitaetsklinikum Koeln
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 10117
        • Rekruttering
        • Charite Universitaetsmedizin Berlin - Campus Mitte

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ABBV-CLS-628 Dose A

Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
Medicin: ABBV-CLS-628

IntraVenous Infusion
Eksperimentel: ABBV-CLS-628 Dose B

Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
Medicin: ABBV-CLS-628

IntraVenous Infusion
Eksperimentel: ABBV-CLS-628 Dose C

Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
Medicin: ABBV-CLS-628

IntraVenous Infusion
Placebo komparator: Placebo

Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
Medicin: Placebo

IntraVenous Infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Calico Life Sciences LLC

Efterforskere

  • Studieleder: Study Director, Calico Life Sciences LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. juni 2025

Primær færdiggørelse (Anslået)

1. august 2029

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

25. marts 2025

Først indsendt, der opfyldte QC-kriterier

25. marts 2025

Først opslået (Faktiske)

30. marts 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M25-147
  • 2024-517143-31-00 (Anden identifikator: EU CT)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner