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Taking peoplePhase 2

Tests ABBV-CLS-628 in adults with polycystic kidney disease

Tests ABBV-CLS-628 against placebo in adults with polycystic kidney disease.

Key facts

Who runs it
Calico Life Sciences LLC
Where
Dordrecht, Groningen, Leiden, and Rotterdam, NetherlandsSee the 4 sitesAlso in 11 other countries, 87 sites
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)
Status
Recruiting
Phase
Phase 2
People taking part
240 people, planned
Started
9 Jun 2025
Expected to end
Aug 2029
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ABBV-CLS-628
  • Placebo
Record updated
6 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Netherlands

Also in 11 other countries, 87 sites

  • Albert Schweitzer ZiekenhuisDordrecht, NetherlandsNo longer taking part
  • Universitair Medisch Centrum GroningenGroningen, NetherlandsNo longer taking part
  • Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsNo longer taking part
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsNo longer taking part

About the trial

What the trial wants to find out

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

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.

The 4 groups in the trial

  • ABBV-CLS-628 Dose ATreatment being tested

    Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.

    Treatment: ABBV-CLS-628

  • ABBV-CLS-628 Dose BTreatment being tested

    Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.

    Treatment: ABBV-CLS-628

  • ABBV-CLS-628 Dose CTreatment being tested

    Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.

    Treatment: ABBV-CLS-628

  • PlaceboPlacebo, for comparison

    Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests ABBV-CLS-628 in adults with polycystic kidney diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06902558, who can take part
Publications
Record updated
6 October 2026