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
- Oshawa and Toronto, CanadaSee the 4 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 55 with autosomal dominant polycystic kidney disease (ADPKD) whose kidneys still work to a moderate degree. It tests the drug ABBV-CLS-628 against a placebo.
- Age
- 18 Years to 55 Years
- Sex
- All sexes can join.
- Disease stage
- ADPKD Class 1C, 1D, or 1E on the Mayo Clinic Imaging Classification. Kidney function (eGFR) of 30 or more and less than 90 mL/min/1.73 m^2 at screening.
- Earlier treatment
- People cannot be receiving current treatments for ADPKD such as non-approved medications or lifestyle changes.
Main reasons for not taking part
- Current interventions to treat ADPKD, such as non-approved medications or lifestyle changes
- Other medical diseases, disorders, or conditions listed in the trial protocol
Read by machine on 11 November 2026.
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 Canada
- Lakeridge Health Corporation-OshawaOshawa, CanadaNot yet recruiting
- Humber River HospitalToronto, CanadaNot yet recruiting
- St. Michael's HospitalToronto, CanadaNot yet recruiting
- Toronto General Hospital, University Health NetworkToronto, CanadaNot yet recruiting
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.