NCT06902558RecruitingPhase 2
ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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)
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 25 Mar 2025
- Start date
- 9 Jun 2025
- Primary completion date
- Aug 2029
- Lead sponsor
- Calico Life Sciences LLC
- Diseases
- Polycystic kidney disease
- NCT number
- NCT06902558
- EU CT number
- 2024-517143-31-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 240
- From 9 Jun 2025 to the primary completion date, Aug 2029
- 91 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.
Other illness
- Any exclusionary medical diseases, disorders, or conditions as described in the protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (91)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Lakeridge Health Corporation-Oshawa Coordinator of this site? Confirm its status | Oshawa | Canada | Not yet recruiting |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Toronto General Hospital, University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Humber River Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Fundació Puigvert Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Active, not recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Active, not recruiting |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 03 | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Coordinator of this site? Confirm its status | Bari | Italy | Active, not recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Recruiting |
| National Hospital Org Chiba Medical Center Chibahigashi National Hospital Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| National Hospital Organization Kyoto Medical Center Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Hallym University Kangnam Sacred Heart Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| SMG-SNU Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. Coordinator of this site? Confirm its status | Almada | Portugal | Active, not recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Active, not recruiting |
| Unidade Local De Saúde De Lisboa Ocidental E.P.E. Coordinator of this site? Confirm its status | Carnaxide | Portugal | Active, not recruiting |
| Unidade Local de Saude do Algarve E.P.E. Coordinator of this site? Confirm its status | Faro | Portugal | Active, not recruiting |
| Servico de Saude da Regiao Autonoma Da Madeira EPERAM Coordinator of this site? Confirm its status | Funchal | Portugal | Active, not recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Arlington Nephrology Coordinator of this site? Confirm its status | Arlington | United States | Withdrawn |
| Emory University School Of Medicine - Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Northeast Clinical Research Center Coordinator of this site? Confirm its status | Bethlehem | United States | Recruiting |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| CARE-Boise Kidney Coordinator of this site? Confirm its status | Boise | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Not yet recruiting |
| Nephrology Associates - Chattanooga - East Third Street Coordinator of this site? Confirm its status | Chattanooga | United States | Recruiting |
| Northwestern University Feinberg School of Medicine Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Horizon Research Group - Coral Gables Coordinator of this site? Confirm its status | Coral Gables | United States | Withdrawn |
| Renal Disease Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| South Florida Research Institute Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Recruiting |
| Valiance Clinical Research: Huntington Park Coordinator of this site? Confirm its status | Huntington Park | United States | Recruiting |
| Care Institute - Idaho Falls Coordinator of this site? Confirm its status | Idaho Falls | United States | Recruiting |
| Nature Coast Clinical Research - Inverness Coordinator of this site? Confirm its status | Inverness | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Mayo Clinic Hospital - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Knoxville Kidney Center Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Academic Medical Research Institute (AMRI) - Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Panax Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| University of Miami Don Suffer Clinical Research Building Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| The Vanderbilt University Medical Center (VUMC) Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Rogosin Institute Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| UC Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| National Institute of Clinical Research - Pomona Coordinator of this site? Confirm its status | Pomona | United States | Recruiting |
| Mayo Clinic Hospital - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Infigo Clinical Research Coordinator of this site? Confirm its status | Sanford | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| University of California Los Angeles Medical Center Coordinator of this site? Confirm its status | Santa Monica | United States | Not yet recruiting |
| Swedish Medical Center_Seattle Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| St. Clair Nephrology Coordinator of this site? Confirm its status | Shelby | United States | Recruiting |
| Washington University School of Medicine - St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Brookview Hills Research Associates Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
Related publications
- Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease.Kidney360 · 2026 · PMID 41385299
- The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care.Clin J Am Soc Nephrol · 2026 · PMID 41348481
This page is information, not medical advice. Discuss any trial with your doctor.