Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study of ABBV-CLS-628 to evaluate safety and effectiveness in adults with Autosomal Dominant Polycystic Kidney Disease

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Autosomal Dominant Polycystic Kidney Disease (ADPKD), a genetic condition where fluid-filled cysts develop in the kidneys, causing them to enlarge and potentially lose function over time. The study aims to evaluate a new medication called ABBV-CLS-628, which is given through intravenous administration, along with a placebo to determine if the treatment is safe and effective for adults with this condition.

The study medication ABBV-CLS-628 is a type of monoclonal antibody, which is a protein designed to work with the body's immune system. During the study, participants will receive either the study medication or a placebo through an injection into a vein. The treatment period will last approximately 96 weeks, during which the size of the kidneys and their function will be monitored.

Throughout the study, various measurements will be taken to track changes in kidney size using MRI scans and to monitor kidney function. The study will involve regular visits to evaluate how well the treatment is working and to check for any potential side effects. Participants will be randomly assigned to either receive the actual medication or the placebo, and neither the participants nor the study doctors will know which treatment is being given.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and qualification

    Your eligibility for the study will be evaluated based on specific criteria, including age (18-55 years), diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD), and kidney function tests.

    Medical imaging will be performed to confirm your ADPKD classification (Class 1C, 1D, or 1E according to Mayo Clinic Classification).

    Laboratory tests will check your kidney function (eGFR must be between 30 and 90 mL/min/1.73 m²).

  2. Step 2

    Study medication assignment

    You will be randomly assigned to receive either ABBV-CLS-628 or placebo through intravenous administration.

    The study is double-blind, meaning neither you nor the study staff will know which treatment you are receiving.

  3. Step 3

    Treatment period - First 48 weeks

    You will receive the assigned treatment (ABBV-CLS-628 or placebo) through intravenous infusion.

    Your total kidney volume (TKV) will be measured using MRI at week 48.

    Regular monitoring of your kidney function will occur throughout this period.

  4. Step 4

    Treatment period - Weeks 49-96

    Treatment continues with the same medication assigned at the start.

    Final MRI scan will be performed at week 96 to measure your total kidney volume.

    Final assessment of your kidney function (eGFR) will be conducted.

  5. Step 5

    Study completion

    The study will evaluate how the treatment affected your kidney volume and function over the 96-week period.

    Total duration of your participation will be approximately 2 years.

Who can join the trial?

8 criteria

  • Must sign an informed consent form approved by an ethics committee before starting any study procedures
  • Age between 18 and 55 years old at the time of screening
  • Must have confirmed diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
  • Must have ADPKD classified as Class 1C, 1D, or 1E according to Mayo Clinic Imaging Classification system
  • Must have kidney function test (eGFR) results between 30 and 90 mL/min/1.73 m2 (eGFR measures how well your kidneys filter waste from your blood)
  • Women must have negative pregnancy tests:
    • Blood test at screening
    • Urine test at the start of the study
    • Women who can become pregnant must agree to use two highly effective forms of birth control from the first day of the study

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 65 years
  • Women who are pregnant or breastfeeding
  • Severe kidney failure requiring dialysis (a procedure to remove waste products from blood when kidneys don't work properly)
  • History of kidney transplant
  • Uncontrolled high blood pressure (systolic pressure above 160 mmHg or diastolic pressure above 100 mmHg)
  • Active liver disease or significant liver function abnormalities
  • History of heart attack or stroke in the past 6 months
  • Current participation in other clinical trials
  • Known allergies to similar medications
  • Major surgery planned during the study period
  • Serious mental health conditions that could affect participation
  • Use of prohibited medications that might interact with the study drug
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

ABBV-CLS-628 is an investigational medication being studied for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). This medication is currently being tested to determine if it can safely and effectively help patients who have this inherited kidney condition. The medication is in Phase 2 of clinical development, which means it is being tested to evaluate both its safety and how well it works in patients with ADPKD.

What is already known about the treatment

ABBV-CLS-628 - A novel investigational drug currently undergoing Phase 2 clinical trials for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The medication is being evaluated in a multicenter, randomized, double-blind, placebo-controlled study to assess its safety and efficacy in adult patients. While the specific mechanism of action and form of administration are not disclosed in the available data, this experimental treatment represents a potential new therapeutic option for managing ADPKD, a genetic disorder affecting kidney function. The study is focused on determining whether ABBV-CLS-628 can provide beneficial effects for patients with this inherited kidney condition.

Investigated diseases

Autosomal Dominant Polycystic Kidney Disease - A genetic disorder that causes multiple cysts to form in the kidneys. The condition is characterized by the progressive development of fluid-filled sacs that gradually replace normal kidney tissue. These cysts can grow very large and multiply over time, leading to enlarged kidneys. The disease typically becomes apparent in adulthood, though it can occur earlier. As the cysts grow and multiply, they can affect kidney function and structure. The condition is inherited, meaning it can be passed from parents to children.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517143-31-00Protocol codeM25-147Estimated enrolment240 patientsSponsorCalico Life Sciences LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.