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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Autosomal Dominant Polycystic Kidney Disease

In brief

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 facts

Study ID

NCT06902558

Run by

Calico Life Sciences LLC

People needed

240

Starts

2025-06-09

Expected to finish

2029-08-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Hospital - Rochester — Rochester, Minnesota, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Valiance Clinical Research - Huntington Park — Huntington Park, California, United States (enrolling)
• National Institute of Clinical Research - Pomona — Pomona, California, United States (enrolling)
• University Of California, San Francisco — San Francisco, California, United States (enrolling)
• Academic Medical Research Institute (AMRI) - Los Angeles — Los Angeles, California, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• UC Irvine Medical Center — Orange, California, United States (enrolling)
• South Florida Research Institute — Fort Lauderdale, Florida, United States (enrolling)
• Nature Coast Clinical Research - Inverness — Inverness, Florida, United States (enrolling)
• Mayo Clinic Hospital Jacksonville — Jacksonville, Florida, United States (enrolling)
• Panax Clinical Research — Miami, Florida, United States (enrolling)
• University of Miami Don Suffer Clinical Research Building — Miami, Florida, United States (enrolling)
• Infigo Clinical Research — Sanford, Florida, United States (enrolling)
• Emory University School Of Medicine - Atlanta — Atlanta, Georgia, United States (enrolling)
• CARE-Boise Kidney — Boise, Idaho, United States (enrolling)
• CARE Institute - Idaho Falls — Idaho Falls, Idaho, United States (enrolling)
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University Of Michigan — Ann Arbor, Michigan, United States (enrolling)
• St. Clair Nephrology — Shelby, Michigan, United States (enrolling)
• Washington University School of Medicine - St Louis — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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