Tests ABBV-CLS-628 in adults with polycystic kidney disease
Tests ABBV-CLS-628 against placebo in adults with polycystic kidney disease.
Plain-language title generated from the registry record
Registry title: ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Key facts
- Where
- Ann Arbor, Arlington, Atlanta, Bethlehem, Birmingham, Boise, Boston, Chapel Hill, Charleston, Chattanooga, Chicago, Coral Gables, Dallas, Fort Lauderdale, Huntington Park, Idaho Falls, Inverness, Iowa City, Jacksonville, Kansas City, Knoxville, Los Angeles, Miami, Nashville, New Haven, New York, Orange, Philadelphia, Pomona, Rochester, San Francisco, Sanford, Santa Monica, Seattle, Shelby, St Louis, and Winston-Salem, United StatesSee the 40 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT06902558, who can take part
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- Arlington NephrologyArlington, United StatesNo longer taking part
- Emory University School Of Medicine - AtlantaAtlanta, United StatesTaking people
- Northeast Clinical Research CenterBethlehem, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- CARE-Boise KidneyBoise, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- Tufts Medical CenterBoston, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesNot yet recruiting
- Nephrology Associates - Chattanooga - East Third StreetChattanooga, United StatesTaking people
- Northwestern University Feinberg School of MedicineChicago, United StatesTaking people
- Horizon Research Group - Coral GablesCoral Gables, United StatesNo longer taking part
- Renal Disease Research InstituteDallas, United StatesTaking people
- South Florida Research InstituteFort Lauderdale, United StatesTaking people
- Valiance Clinical Research: Huntington ParkHuntington Park, United StatesTaking people
- Care Institute - Idaho FallsIdaho Falls, United StatesTaking people
- Nature Coast Clinical Research - InvernessInverness, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- Mayo Clinic Hospital - JacksonvilleJacksonville, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Knoxville Kidney CenterKnoxville, United StatesTaking people
- Academic Medical Research Institute (AMRI) - Los AngelesLos Angeles, United StatesTaking people
- Panax Clinical ResearchMiami, United StatesTaking people
- University of Miami Don Suffer Clinical Research BuildingMiami, United StatesTaking people
- The Vanderbilt University Medical Center (VUMC)Nashville, United StatesNot yet recruiting
- Yale University School Of MedicineNew Haven, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Rogosin InstituteNew York, United StatesNot yet recruiting
- UC Irvine Medical CenterOrange, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- National Institute of Clinical Research - PomonaPomona, United StatesTaking people
- Mayo Clinic Hospital - RochesterRochester, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- Infigo Clinical ResearchSanford, United StatesTaking people
- University of California Los Angeles Medical CenterSanta Monica, United StatesNot yet recruiting
- Swedish Medical Center_SeattleSeattle, United StatesTaking people
- St. Clair NephrologyShelby, United StatesTaking people
- Washington University School of Medicine - St. LouisSt Louis, United StatesTaking people
- Brookview Hills Research AssociatesWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Calico Life Sciences LLC
- Trial code
- NCT06902558EU 2024-517143-31-00
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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.