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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medizinische Hochschule Hannover Hanover Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Universitario 12 De Octubre Madrid Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Hospital Universitario Virgen De Las Nieves Granada Spain
Servico de Saude da Regiao Autonoma Da Madeira EPERAM Funchal Portugal
Fundacio Puigvert Barcelona Spain
Virgen del Rocío University Hospital Sevilla Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
Coymmfuel Ulhmqsbitgwebp Safwoxdlf Woluwe-Saint-Lambert Belgium
Lantq Uatwuhjmsfch Mzupaos Csdiqow (igcyj Leiden The Netherlands
Ubelgkyjvqqj Mzbvtoq Cbkwtjp Gwmruhogf Groningen The Netherlands
Ufhzmjgzsx Hitnrtrl Ctmecwz Cologne Germany
Aoeyhxkvwr Patidblt Hjytcmlj Db Mpjuwobyv Marseille France
Exxllqy Uevumeqzeuhp Mwmoxxs Czuykpr Rauzhxnhf (borchxw Mpw Rotterdam The Netherlands
Urgyeukdff Dxvpx Sppia Dj Rbhn Ln Sixbxssm Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
05.07.2025
France France
Not recruiting
05.07.2025
Germany Germany
Not recruiting
05.07.2025
Italy Italy
Not recruiting
05.07.2025
Portugal Portugal
Not recruiting
05.07.2025
Spain Spain
Not recruiting
05.07.2025
The Netherlands The Netherlands
Not recruiting
05.07.2025

Trial locations

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.

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 ID:
2024-517143-31-00
Protocol code:
M25-147
Trial Phase:
Therapeutic exploratory (Phase II)

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