Polycystic Kidney Disease Clinical Trials

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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)

Status: Recruiting
Location: See all (91) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
Valiance Clinical Research - Huntington Park
RECRUITING
Huntington Park
Academic Medical Research Institute (AMRI) - Los Angeles
RECRUITING
Los Angeles
UC Irvine Medical Center
RECRUITING
Orange
National Institute of Clinical Research - Pomona
RECRUITING
Pomona
University Of California, San Francisco
RECRUITING
San Francisco
University of California Los Angeles Medical Center
NOT_YET_RECRUITING
Santa Monica
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Florida
Horizon Research Group - Coral Gables
WITHDRAWN
Coral Gables
South Florida Research Institute
RECRUITING
Fort Lauderdale
Nature Coast Clinical Research - Inverness
RECRUITING
Inverness
Mayo Clinic Hospital Jacksonville
RECRUITING
Jacksonville
Panax Clinical Research
RECRUITING
Miami
University of Miami Don Suffer Clinical Research Building
RECRUITING
Miami
Infigo Clinical Research
RECRUITING
Sanford
Georgia
Emory University School Of Medicine - Atlanta
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Idaho
CARE-Boise Kidney
RECRUITING
Boise
CARE Institute - Idaho Falls
RECRUITING
Idaho Falls
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Michigan
University Of Michigan
RECRUITING
Ann Arbor
St. Clair Nephrology
RECRUITING
Shelby
Minnesota
Mayo Clinic Hospital - Rochester
RECRUITING
Rochester
Missouri
Washington University School of Medicine - St Louis
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Brookview Hills Research Associates
RECRUITING
Winston-salem
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Rogosin Institute
NOT_YET_RECRUITING
New York
Pennsylvania
Northeast Clinical Research Center
RECRUITING
Bethlehem
University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Tennessee
Nephrology Associates - Chattanooga - East Third Street
RECRUITING
Chattanooga
Knoxville Kidney Center
RECRUITING
Knoxville
The Vanderbilt University Medical Center (VUMC)
NOT_YET_RECRUITING
Nashville
Texas
Arlington Nephrology
WITHDRAWN
Arlington
Renal Disease Research Institute
RECRUITING
Fort Worth
Washington
Swedish Medical Center - Seattle
RECRUITING
Seattle
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Royal Brisbane and Women's Hospital
RECRUITING
Brisbane
Fiona Stanley Hospital
RECRUITING
Murdoch
Westmead Hospital
RECRUITING
Westmead
Belgium
Cliniques Universitaires UCL Saint-Luc
RECRUITING
Brussels
UZ Leuven
RECRUITING
Leuven
CHU de Liege
RECRUITING
Liège
Canada
Lakeridge Health Corporation-Oshawa
NOT_YET_RECRUITING
Oshawa
Humber River Hospital
NOT_YET_RECRUITING
Toronto
St. Michael's Hospital
NOT_YET_RECRUITING
Toronto
Toronto General Hospital-University Health Network
NOT_YET_RECRUITING
Toronto
France
CHU Brest - Hôpital de la Cavale Blanche
RECRUITING
Brest
Hopital Edouard Herriot
RECRUITING
Lyon
Hopital de la Conception
RECRUITING
Marseille
Hopital Universitaire Necker Enfants Malades
RECRUITING
Paris
CHU Toulouse - Hôpital Rangueil
RECRUITING
Toulouse
Germany
Charite Universitaetsmedizin Berlin - Campus Mitte
RECRUITING
Berlin
Universitaetsklinikum Koeln
RECRUITING
Cologne
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitaetsklinikum Heidelberg
NOT_YET_RECRUITING
Heidelberg
TUM Klinikum rechts der Isar
RECRUITING
Munich
Italy
A.O.U. Consorziale Policlinico di Bari
NOT_YET_RECRUITING
Bari
AOU di Modena - Ospedale di Modena
NOT_YET_RECRUITING
Modena
Azienda Ospedaliero-Universitaria Policlinico Umberto I
RECRUITING
Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica
NOT_YET_RECRUITING
Rome
Japan
Juntendo University Hospital
RECRUITING
Bunkyō-ku
National Hospital Org Chiba Medical Center Chibahigashi National Hospital
RECRUITING
Chiba
National Hospital Organization Kyoto Medical Center
RECRUITING
Kyoto
Hokkaido University Hospital
RECRUITING
Sapporo
Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk
RECRUITING
Dordrecht
Universitair Medisch Centrum Groningen
WITHDRAWN
Groningen
LUMC
RECRUITING
Leiden
Erasmus Medisch Centrum
NOT_YET_RECRUITING
Rotterdam
Portugal
Unidade Local de Saude de Almada-Seixal, EPE
RECRUITING
Almada
2CA-Braga, Hospital de Braga
RECRUITING
Braga
Unidade Local de Saude do Algarve, EPE
RECRUITING
Faro
Centro Hospitalar Do Funchal
NOT_YET_RECRUITING
Funchal
Hospital Curry Cabral
RECRUITING
Lisbon
Unidade Local de Saude de Lisboa Ocidental, EPE
RECRUITING
Lisbon
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Hallym University Kangnam Sacred Heart Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
SMG-SNU Boramae Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Spain
Fundacio Puigvert
RECRUITING
Barcelona
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital Universitari de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
NOT_YET_RECRUITING
Seville
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Contact Information
Primary
Calico Clinical Trial Communication
clinicaltrialcommunication@calicolabs.com
650-754-6200
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2029-08
Participants
Target number of participants: 240
Treatments
Experimental: ABBV-CLS-628 Dose A
Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
Experimental: ABBV-CLS-628 Dose B
Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
Experimental: ABBV-CLS-628 Dose C
Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
Placebo_comparator: Placebo
Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
Sponsors
Leads: Calico Life Sciences LLC

This content was sourced from clinicaltrials.gov