Recruiting

Phase 2

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

Sponsor:

Calico Life Sciences LLC

Code:

NCT06902558

Conditions

Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

ABBV-CLS-628

Placebo

Study Details

Brief 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.

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Study ID

NCT06902558

Start date

Jun 9, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ABBV-CLS-628

IntraVenous Infusion

Placebo

IntraVenous Infusion

Primary outcome measure

Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) [ Time Frame: Week 96 ]
Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 118 weeks ]

Central Contacts and Locations

Central contacts

Calico Clinical Trial Communication

650-754-6200 clinicaltrialcommunication@calicolabs.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Maria El Hachem

205-975-0549 mehachem@uabmc.edu

Valiance Clinical Research - Huntington Park

Recruiting

Huntington Park, California, United States, 90255

Contacts

Josh Lai

323-484-0508 j.lai@ValianceClinicalResearch.com

Academic Medical Research Institute (AMRI) - Los Angeles

Recruiting

Los Angeles, California, United States, 90022

Contacts

Mohamed Shahawy, MD, MPH

323-725-0051 md@amrionline.net

UC Irvine Medical Center

Recruiting

Orange, California, United States, 92868-3201

Contacts

Ahmad Walid Roshan

714-509-6271 ahmadwar@hs.uci.edu

National Institute of Clinical Research - Pomona

Recruiting

Pomona, California, United States, 91768

Contacts

National Institute of Clinical Research, Inc.

323-725-0657 nicr@nicresearch.com

University Of California, San Francisco

Recruiting

San Francisco, California, United States, 94143-2202

Contacts

Meyeon Park, MD

415-514-1122 PKD@ucsf.edu

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Jessica Li

203-737-1091 jessica.a.li@yale.edu

Romani Osbourne

203-737-1091 romani.osbourne@yale.edu

South Florida Research Institute

Recruiting

Fort Lauderdale, Florida, United States, 33313

Contacts

Marie Pierre Louis

954-739-4474 marie.pierrelouis@sfriresearch.com

Nature Coast Clinical Research - Inverness

Recruiting

Inverness, Florida, United States, 34452-4717

Contacts

Rafik Abadier

352-341-2100 rabadier@flourishresearch.com

Mayo Clinic Hospital Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Mia Schell

904-953-3671 schell.mia@mayo.edu

Panax Clinical Research

Recruiting

Miami, Florida, United States, 33014

Contacts

Robert G. Perry, MD

305-698-4500 rperry@panaxcr.com

University of Miami Don Suffer Clinical Research Building

Recruiting

Miami, Florida, United States, 33136

Contacts

Carlos Bidot

305-243-8793 cbidot2@med.miami.edu

Infigo Clinical Research

Recruiting

Sanford, Florida, United States, 32771

Contacts

Leianna Lewis

info@infigoresearch.com

Emory University School Of Medicine - Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Frederic Rahbari Oskoui

404-727-2590 frahbar@emory.edu

CARE-Boise Kidney

Recruiting

Boise, Idaho, United States, 83706

Contacts

Samantha Stinemetz

208-996-1944 Samantha@CardioRenalInstitute.com

CARE Institute - Idaho Falls

Recruiting

Idaho Falls, Idaho, United States, 83404

Contacts

Carolina Saldana

208-984-2273 Carolina@cardiorenalinstitute.com

Northwestern University Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611-2927

Contacts

Patrick Fox

312-503-1887 patrick.fox@northwestern.edu

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Jissele Verdinez

319-384-5369 jissele-verdinez@uiowa.edu

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Jordan Elliott

jelliott11@kumc.edu

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111-1552

Contacts

Olaniyi Ogunbodede

617-636-5076 olaniyi.ogunbodede@tuftsmedicine.org

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Peter Czarnecki, MD

617-632-9890 nephrologyadminsupport@bidmc.harvard.edu

University Of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109-5000

Contacts

Michael Heung, MD

734-936-6489 mheung@umich.edu

St. Clair Nephrology

Recruiting

Shelby, Michigan, United States, 48315

Contacts

Rosemarie Henschel, RN

313-432-6273 rhenschel@scsp.net

Mayo Clinic Hospital - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Ryan Helland

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

Washington University School of Medicine - St Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Seth Goldberg, MD

314-362-9096 sgoldber@wustl.edu

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Icahn School of Medicine Mount Sinai

212-241-2339

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599-0001

Contacts

Emily Chang, MD

919-445-2621 emily_chang@med.unc.edu

Brookview Hills Research Associates

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Janice Rogers

336-245-6330 jrogers@brookviewhills.com

Northeast Clinical Research Center

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Contacts

Stephanie Hanzl, RN

610-433-4100 steph.hanzl@necresearch.org

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Krishna Kallem

krishna.kallem@pennmedicine.upenn.edu

Simin Goral, MD

simin.goral@pennmedicine.upenn.edu

Nephrology Associates - Chattanooga - East Third Street

Recruiting

Chattanooga, Tennessee, United States, 37404

Contacts

Southeast Renal Research Institute

423-826-8003 research@nephassociates.com

Knoxville Kidney Center

Recruiting

Knoxville, Tennessee, United States, 37923

Contacts

Tammy Conger

865-692-3462 tconger@knoxvillekidneycenter.com

Renal Disease Research Institute

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Caren Swift

214-366-6094 swiftc@DNEPH.com

Swedish Medical Center - Seattle

Recruiting

Seattle, Washington, United States, 98104

Contacts

Adel Islam

206-215-6532 adel.islam@swedish.org

More Information

Sponsor

Calico Life Sciences LLC

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
ABBV-CLS-628

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Calico Life Sciences LLC on 2026-09-01.