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

Part of paid clinical trials in Garden Grove, California.

Sponsor
Calico Life Sciences LLC
Study ID
NCT06902558
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • ABBV-CLS-628 — DRUG
    IntraVenous Infusion
  • Placebo — DRUG
    IntraVenous Infusion

Study Details

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.

Key Dates

Start date
Jun 9, 2025
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ABBV-CLS-628 Dose A
    Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
  • Experimental: ABBV-CLS-628 Dose B
    Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
  • Experimental: ABBV-CLS-628 Dose C
    Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
  • Placebo Comparator: Placebo
    Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.

Primary Outcome Measure

Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) [ Time Frame: Week 96 ]

Central Contacts

Locations (35)

FacilityCityStateZIPSite coordinators
National Institute of Clinical Research - Garden Grove /ID# 271418Garden GroveCalifornia92844-
Valiance Clinical Research - Huntington Park /ID# 270634Huntington ParkCalifornia90255-
Academic Medical Research Institute - Los Angeles /ID# 270502Los AngelesCalifornia90022-
UC Irvine Medical Center /ID# 270811OrangeCalifornia92868-3201-
University Of California, San Francisco /ID# 270326San FranciscoCalifornia94143-2202-
Yale University School of Medicine /ID# 270675New HavenConnecticut06510-
Horizon Research Group - Coral Gables /ID# 270857Coral GablesFlorida33134-
South Florida Research Institute /ID# 270848Fort LauderdaleFlorida33313-
Nature Coast Clinical Research - Inverness /ID# 270875InvernessFlorida34452-4717-
Mayo Clinic Hospital Jacksonville /ID# 271011JacksonvilleFlorida32224-
Panax Clinical Research /ID# 270851MiamiFlorida33014-
Infigo Clinical Research /ID# 270844SanfordFlorida32771-
Emory University School Of Medicine - Atlanta /ID# 271947AtlantaGeorgia30322-
CARE-Boise Kidney /ID# 270628BoiseIdaho83706-
CARE Institute - Idaho Falls /ID# 272005Idaho FallsIdaho83404-
Northwestern University Feinberg School of Medicine /ID# 271409ChicagoIllinois60611-2927-
University of Iowa /ID# 270492Iowa CityIowa52242-
University of Kansas Medical Center /ID# 271946Kansas CityKansas66160-
Beth Israel Deaconess Medical Center /ID# 271408BostonMassachusetts02215-
Tufts Medical Center /ID# 270323BostonMassachusetts02111-1552-
University Of Michigan /ID# 270436Ann ArborMichigan48109-5000-
St. Clair Nephrology /ID# 271445ShelbyMichigan48315-
Mayo Clinic Hospital Rochester /ID# 270428RochesterMinnesota55905-
Washington University /ID# 271436St LouisMissouri63110-
Icahn School of Medicine at Mount Sinai /ID# 271440New YorkNew York10029-
University of North Carolina at Chapel Hill /ID# 274800Chapel HillNorth Carolina27599-0001-
Brookview Hills Research Associates /ID# 271449Winston-SalemNorth Carolina27103-
Northeast Clinical Research Center /ID# 270838BethlehemPennsylvania18017-
University of Pennsylvania /ID# 270301PhiladelphiaPennsylvania19104-
Nephrology Associates - Chattanooga - East Third Street /ID# 270701ChattanoogaTennessee37404-
Knoxville Kidney Center /ID# 270706KnoxvilleTennessee37923-
Arlington Nephrology /ID# 270494ArlingtonTexas76015-
Renal Disease Research Institute /ID# 270339Fort WorthTexas76104-
University of Virginia /ID# 270329CharlottesvilleVirginia22908-
Swedish Medical Center - Seattle /ID# 270344SeattleWashington98104-

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National Institute of Clinical Research - Garden Grove· Garden Grove, CAValiance Clinical Research - Huntington Park· Huntington Park, CAAcademic Medical Research Institute - Los Angeles· Los Angeles, CAUC Irvine Medical Center· Orange, CAUniversity Of California, San Francisco· San Francisco, CAYale University School of Medicine· New Haven, CT

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