Clinical trial • Phase II • Nephrology | Rare Disease
ABBV-CLS-628 for Autosomal dominant polycystic kidney disease (ADPKD)
Phase II trial of ABBV-CLS-628 for Autosomal dominant polycystic kidney disease (ADPKD).
Overview
- Trial Therapeutic Area
- Nephrology | Rare Disease
- Trial Disease
- Autosomal dominant polycystic kidney disease (ADPKD)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody | Other
Key dates
- Initial CTIS Submission Date
- 20-03-2025
- First CTIS Authorization Date
- 07-07-2025
Trial design
Randomised, placebo for abbv-cls-628 (placebo comparator); dose and schedule not specified.-controlled Phase II trial in Spain, Netherlands, Portugal and others.
- Randomised
- Yes
- Comparator
- Placebo for ABBV-CLS-628 (placebo comparator); dose and schedule not specified.
- Target Sample Size
- 142
- Trial Duration For Participant
- 672
Eligibility
Recruits 142 Vulnerable population not selected (isVulnerablePopulationSelected=false). Participants must voluntarily sign and date an informed consent approved by an independent ethics committee (IEC)/institutional review board (IRB) prior to initiation of any washout, screening or study-specific procedures. Age entry limits are 18 to 55 years (adults only); assent for minors not applicable..
- Pregnancy Exclusion
- Negative serum pregnancy test at Screening and negative urine pregnancy test at baseline.
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false). Participants must voluntarily sign and date an informed consent approved by an independent ethics committee (IEC)/institutional review board (IRB) prior to initiation of any washout, screening or study-specific procedures. Age entry limits are 18 to 55 years (adults only); assent for minors not applicable.
Inclusion criteria
- {"criterion_text":"- Trial participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any washout, screening or study-specific procedures.\n- Age 18 (or higher age limit defined per regional definitions) to 55 years of age, both inclusive at the time of consent.\n- Diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD).\n- ADPKD Classe 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD.\n- eGFR >= 30 mL/min/1.73 m2 and < 90 mL/min/1.73 m2 , using the CKD-EPI equation at Screening.\n- Negative serum pregnancy test at Screening and negative urine pregnancy test at baseline.\n- Female trial participants of childbearing potential enrolled must agree to use two forms of protocol-specified, contraception, one of which is highly effective from Study Day 1."}
Exclusion criteria
- {"criterion_text":"- Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.\n- Positive result on the urine drug screen at Screening unless explained by concomitant medication use.\n- Concurrent participation in any other interventional trial.\n- Any exclusionary medical diseases, disorders, or conditions.\n- Hypertension not controlled by antihypertensive therapy (per investigator's judgment) at screening and baseline.\n- History of Renal Replacement Therapy.\n- Anticipated need for dialysis or transplantation within the next year.\n- Any active infections including but not limited to the following: Positive for HIV, HBV, HCV.\n- Immunocompromised per investigator's judgment.\n- History of clinically significant (per investigator's discretion) drug or alcohol abuse within the last 6 months prior to Screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Cumulative rate of change from baseline in TKV by MRI at Week 96.","definition_or_measurement_approach":"Change from baseline in total kidney volume (TKV) measured by MRI at Week 96 (measured as cumulative rate of change vs baseline)."}
Secondary endpoints
- {"endpoint_text":"- Absolute change in eGFR from baseline at Week 96.","definition_or_measurement_approach":"Absolute change from baseline in estimated glomerular filtration rate (eGFR) at Week 96 (method not specified in endpoint text)."}
- {"endpoint_text":"- Cumulative rate of change from baseline in TKV by MRI at Week 48.","definition_or_measurement_approach":"Change from baseline in total kidney volume (TKV) measured by MRI at Week 48 (measured as cumulative rate of change vs baseline)."}
Recruitment
- Planned Sample Size
- 142
- Recruitment Window Months
- 49
- Consent Approach
- Informed consent must be voluntarily signed and dated by the participant prior to initiation of any washout, screening or study-specific procedures (IEC/IRB-approved). Age eligibility restricts to adults (18–55), so consent is provided by the participant. Country-specific ICF documents are available in local languages (examples in the dossier: Spanish, Dutch, Portuguese, Italian, French, German, English). Optional and pregnancy-specific ICFs are documented per country.
Methods
- Spain: Recruitment arrangements, brochures and flyer documents present (K1_M25-147 ES Recruitment and ICF Procedures_Public; K2_M25-147 ES Recruitment brochure_Public; K2_M25-147 ES Recruitment Flyer_Public) targeting adult patients with ADPKD.
- Netherlands: Recruitment arrangements, brochure and flyer documents present (K1_M25-147 NL Recruitment and ICF Procedures_Public; K2_M25-147 NL Recruitment Brochure_Public Redacted; K2_M25-147 NL Recruitment Flyer_Public) targeting adult patients with ADPKD.
- Portugal: Recruitment arrangements, brochure and flyer and poster documents present (K1 M25-147 PT Recruitment and ICF procedures_Public; K2 M25-147 PT Recruitment Brochure_public redacted; K2 M25-147 PT Recruitment Flyer_public; K2 M25-147 PT Recruitment Poster_public) targeting adult patients with ADPKD.
- Italy: Recruitment brochure, flyer and poster documents present (K1_M25-147 IT Recruitment and ICF Procedures_Public; K2_M25-147 IT Recruitment Brochure_Public Redacted; K2_M25-147 IT Recruitment Flyer_Public; K2_M25-147 IT Recruitment Poster_Public) targeting adult patients with ADPKD.
- Belgium: Recruitment arrangements, brochures and flyers present (K1 M25-147 BE EU CTR Recruitment and ICF Procedures_Public; K2 M25-147 BE Recruitment Brochure/Flyer in local languages) targeting adult patients with ADPKD.
- France: Recruitment arrangements, brochure present (K1 M25-147 FR Recruitment and ICF Procedures; K2 M25-147 FR Recruitment Brochure_Public) targeting adult patients with ADPKD.
- Germany: Recruitment arrangements, brochure and flyer documents present (K1 M25-147 Recruitment and ICF Procedures_Public; K2 M25-147 DE Recruitment Brochure public redacted; K2 M25-147 DE Recruitment Flyer public) targeting adult patients with ADPKD.
Geography
- Total Number Of Sites
- 35
- Total Number Of Participants
- 98
Spain
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 273
- Number Of Sites
- 8
- Number Of Participants
- 28
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Nephrology
- Contact Person Name
- Maria Vanessa Perez Gomez
- Contact Person Email
- mvanessa@fjd.es
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Nephrology
- Contact Person Name
- Rafael Jose Esteban de la Rosa
- Contact Person Email
- rafaelj.esteban@gmail.com
- Site Name
- Bellvitge University Hospital
- Department Name
- Nephrology
- Contact Person Name
- Miguel Hueso Val
- Contact Person Email
- mhueso@idibell.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Nephrology
- Contact Person Name
- Eduardo Gutierrez Martinez
- Contact Person Email
- eduardo.gutierrez@salud.madrid.org
- Site Name
- Fundacio Puigvert
- Department Name
- Nephrology
- Contact Person Name
- Roser Torra Balcells
- Contact Person Email
- rtorra@fundacio-puigvert.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Nephrology
- Contact Person Name
- Jose Luis Rocha Castilla
- Contact Person Email
- jrocha1@us.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Nephrology
- Contact Person Name
- Jose Luis Gorriz Teruel
- Contact Person Email
- jlg.eecc@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-06-2025
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 296
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Nefrologie
- Contact Person Name
- Mahdi Salih
- Contact Person Email
- poli.nefrologie@erasmusmc.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Nefrologie
- Contact Person Name
- Jeroen van der Net
- Contact Person Email
- wetenschap@asz.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Nefrologie
- Contact Person Name
- Ron Gansevoort
- Contact Person Email
- researchsupport@umcg.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Nefrologie
- Contact Person Name
- Harm Spijker
- Contact Person Email
- polinierziekten@lumc.nl
Portugal
- Earliest CTIS Part Ii Submission Date
- 07-05-2025
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 329
- Number Of Sites
- 6
- Number Of Participants
- 21
Sites
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Nephrology
- Contact Person Name
- Fernando Teixeira e Costa
- Contact Person Email
- teixeiraecosta@gmail.com
- Site Name
- Unidade Local De Saude De Lisboa Ocidental E.P.E.
- Department Name
- Nephrology
- Contact Person Name
- Ana Rita Martins
- Contact Person Email
- anarita.mateus@gmail.com
- Site Name
- Unidade Local de Saude do Algarve E.P.E.
- Department Name
- Nephrology
- Contact Person Name
- Ana Cabrita
- Contact Person Email
- anacabrita2@gmail.com
- Site Name
- Servico de Saude da Regiao Autonoma Da Madeira EPERAM
- Department Name
- Nephrology
- Contact Person Name
- Gil Silva
- Contact Person Email
- gil.silva@sesaram.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Nephrology
- Contact Person Name
- Carlos Soares
- Contact Person Email
- carlos.mario.soares@hb.min-saude.pt
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Nephrology
- Contact Person Name
- Rui Barata
- Contact Person Email
- rui.barata@ulssjose.min-saude.pt
Italy
- Earliest CTIS Part Ii Submission Date
- 09-04-2025
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 358
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Dip Chirurgico Medico Odontoiatrico e di Sc. Morfologiche con Interesse Trapiantologico, Oncologico
- Contact Person Name
- Riccardo Magistroni
- Contact Person Email
- riccardo.magistroni@unimore.it
- Site Name
- Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
- Department Name
- U.O.C. Nefrologia, Dialisi e Trapianto
- Contact Person Name
- Loreto Gesualdo
- Contact Person Email
- loreto.gesualdo@uniba.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Department of translational and precision medicine
- Contact Person Name
- Silvia Lai
- Contact Person Email
- silvia.lai@uniroma1.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Nephrology Unit, Dept of Translational Medicine and Surgery
- Contact Person Name
- Giuseppe Grandaliano
- Contact Person Email
- giuseppe.grandaliano@unicatt.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-06-2025
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 295
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- UZ Leuven
- Department Name
- Nephrology
- Contact Person Name
- Bert Bammens
- Contact Person Email
- bert.bammens@uzleuven.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Nephrology
- Contact Person Name
- Nathalie Demoulin
- Contact Person Email
- nathalie.demoulin@saintluc.uclouvain.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Nephrology
- Contact Person Name
- François Jouret
- Contact Person Email
- francois.jouret@chuliege.be
France
- Earliest CTIS Part Ii Submission Date
- 27-05-2025
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 317
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Néphrologie et d'exploration fonctionnelle rénale
- Contact Person Name
- Sandrine LEMOINE
- Contact Person Email
- sandrine.lemoine01@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service de Néphrologie et Transplantation d'organes
- Contact Person Name
- Dominique CHAUVEAU
- Contact Person Email
- chauveau.d@chu-toulouse.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service de Néphrologie et Transplantation rénale
- Contact Person Name
- Stéphane Burtey
- Contact Person Email
- stephaneb@ap-hm.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service de Néphrologie, transplantation rénale et hémodialyse
- Contact Person Name
- Emilie CORNEC-LE GALL
- Contact Person Email
- emilie.cornec-legall@chu-brest.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de néphrologie - Dialyse Adultes
- Contact Person Name
- Bertrand Knebelmann
- Contact Person Email
- bertrand.knebelmann@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 18-06-2025
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 288
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Innerer Medizin X – Klinik fuer Nephrologie
- Contact Person Name
- Claudia Sommerer
- Contact Person Email
- claudia.sommerer@med.uni-heidelberg.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Studienzentrum für Nieren- und Hochdruckerkrankungen
- Contact Person Name
- Jessica Kaufeld
- Contact Person Email
- Studienzentrum@mh-hannove.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik m.S. Nephrologie und Intensivmedizin
- Contact Person Name
- Jan Halbritter
- Contact Person Email
- jan.halbritter@charite.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik II für Innere Medizin
- Contact Person Name
- Roman-Ulrich Mueller
- Contact Person Email
- studienzentrum-medii@uk-koeln.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Abteilung für Nephrologie
- Contact Person Name
- Lutz Renders
- Contact Person Email
- nephrologie.office@mri.tum.de
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- code:3
- Name
- Medidata Solutions Inc.
- Responsibilities
- code:15 (eCOA-clinical outcome assessments); code:7
- Name
- Accellacare Limited
- Responsibilities
- code:15 (Home Health visits)
- Name
- Greenphire LLC
- Responsibilities
- code:15 (Subject Reimbursements)
- Name
- Cytel Inc.
- Responsibilities
- code:15 (DMC Charter)
- Name
- Perceptive Informatics Inc.
- Responsibilities
- code:15 (Imaging)
- Name
- Everest Clinical Research Corporation
- Responsibilities
- code:15 (DMC Charter)
- Name
- Marken LLP
- Responsibilities
- code:15 (Direct to Patient Shipments of IP)
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- code:4
- Name
- Clinical Trial Media Inc.
- Responsibilities
- code:2
- Name
- Veeva Systems Inc.
- Responsibilities
- code:7
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:15 (eCOA-clinical outcome assessments); code:7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"code:2","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"code:15 (Home Health visits)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"code:15 (Subject Reimbursements)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"code:15 (DMC Charter)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"code:15 (Imaging)","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Everest Clinical Research Corporation","duties_or_roles":"code:15 (DMC Charter)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Marken LLP","duties_or_roles":"code:15 (Direct to Patient Shipments of IP)","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ABBV-CLS-628
- Active Substance
- ABBV-CLS-628
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Investigational Product Name
- Placebo for ABBV-CLS-628
- Modality
- Other
Related trials
Other published trials that may interest you.