A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT06902558 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: M25-1472024-517143-31-00
• Study Type: interventional
• Target: 240
• Locations: 11 countries
• Sites: 75

Brief 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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Autosomal Dominant Polycystic Kidney Disease (ADPKD); ABBV-CLS-628

Outcome Measures

Primary Outcomes (2)

• Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)

  TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD).

  Week 96

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to approximately 118 weeks

Secondary Outcomes (4)

• Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline

  Week 96

• Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)

  Week 48

• Absolute Change in eGFR From Baseline

  Week 48

• Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR

  Up to Week 96

Study Arms (4)

ABBV-CLS-628 Dose A

EXPERIMENTAL

Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.

Drug: ABBV-CLS-628

ABBV-CLS-628 Dose B

EXPERIMENTAL

Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.

Drug: ABBV-CLS-628

ABBV-CLS-628 Dose C

EXPERIMENTAL

Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.

Drug: ABBV-CLS-628

Placebo

PLACEBO COMPARATOR

Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.

Drug: Placebo

Interventions

ABBV-CLS-628 DRUG

IntraVenous Infusion

ABBV-CLS-628 Dose A; ABBV-CLS-628 Dose B; ABBV-CLS-628 Dose C

Placebo DRUG

IntraVenous Infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.

Sponsors & Collaborators

• AbbVie: lead
• Calico Life Sciences LLC: collaborator

Study Sites (75)

National Institute of Clinical Research - Garden Grove /ID# 271418

Garden Grove, California, 92844, United States

RECRUITING

Valiance Clinical Research - Huntington Park /ID# 270634

Huntington Park, California, 90255, United States

RECRUITING

Academic Medical Research Institute - Los Angeles /ID# 270502

Los Angeles, California, 90022, United States

RECRUITING

UC Irvine Medical Center /ID# 270811

Orange, California, 92868-3201, United States

RECRUITING

University Of California, San Francisco /ID# 270326

San Francisco, California, 94143-2202, United States

RECRUITING

Yale University School of Medicine /ID# 270675

New Haven, Connecticut, 06510, United States

RECRUITING

Horizon Research Group - Coral Gables /ID# 270857

Coral Gables, Florida, 33134, United States

RECRUITING

South Florida Research Institute /ID# 270848

Fort Lauderdale, Florida, 33313, United States

RECRUITING

Nature Coast Clinical Research - Inverness /ID# 270875

Inverness, Florida, 34452-4717, United States

RECRUITING

Mayo Clinic Hospital Jacksonville /ID# 271011

Jacksonville, Florida, 32224, United States

RECRUITING

Panax Clinical Research /ID# 270851

Miami, Florida, 33014, United States

RECRUITING

Infigo Clinical Research /ID# 270844

Sanford, Florida, 32771, United States

RECRUITING

Emory University School Of Medicine - Atlanta /ID# 271947

Atlanta, Georgia, 30322, United States

RECRUITING

CARE-Boise Kidney /ID# 270628

Boise, Idaho, 83706, United States

RECRUITING

CARE Institute - Idaho Falls /ID# 272005

Idaho Falls, Idaho, 83404, United States

RECRUITING

Northwestern University Feinberg School of Medicine /ID# 271409

Chicago, Illinois, 60611-2927, United States

RECRUITING

University of Iowa /ID# 270492

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Medical Center /ID# 271946

Kansas City, Kansas, 66160, United States

RECRUITING

Tufts Medical Center /ID# 270323

Boston, Massachusetts, 02111-1552, United States

RECRUITING

Beth Israel Deaconess Medical Center /ID# 271408

Boston, Massachusetts, 02215, United States

RECRUITING

University Of Michigan /ID# 270436

Ann Arbor, Michigan, 48109-5000, United States

RECRUITING

St. Clair Nephrology /ID# 271445

Shelby, Michigan, 48315, United States

RECRUITING

Mayo Clinic Hospital Rochester /ID# 270428

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University /ID# 271436

St Louis, Missouri, 63110, United States

RECRUITING

Icahn School of Medicine at Mount Sinai /ID# 271440

New York, New York, 10029, United States

RECRUITING

University of North Carolina at Chapel Hill /ID# 274800

Chapel Hill, North Carolina, 27599-0001, United States

RECRUITING

Brookview Hills Research Associates /ID# 271449

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Northeast Clinical Research Center /ID# 270838

Bethlehem, Pennsylvania, 18017, United States

RECRUITING

University of Pennsylvania /ID# 270301

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Nephrology Associates - Chattanooga - East Third Street /ID# 270701

Chattanooga, Tennessee, 37404, United States

RECRUITING

Knoxville Kidney Center /ID# 270706

Knoxville, Tennessee, 37923, United States

RECRUITING

Arlington Nephrology /ID# 270494

Arlington, Texas, 76015, United States

RECRUITING

Renal Disease Research Institute /ID# 270339

Fort Worth, Texas, 76104, United States

RECRUITING

University of Virginia /ID# 270329

Charlottesville, Virginia, 22908, United States

RECRUITING

Swedish Medical Center - Seattle /ID# 270344

Seattle, Washington, 98104, United States

RECRUITING

Westmead Hospital /ID# 271156

Westmead, New South Wales, 2145, Australia

RECRUITING

Royal Brisbane and Women's Hospital /ID# 271224

Brisbane, Queensland, 4029, Australia

RECRUITING

Royal Adelaide Hospital /ID# 273114

Adelaide, South Australia, 5000, Australia

RECRUITING

Fiona Stanley Hospital /ID# 271173

Murdoch, Western Australia, 6150, Australia

RECRUITING

Cliniques Universitaires UCL Saint-Luc /ID# 270635

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

UZ Leuven /ID# 270638

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

CHU de Liege /ID# 270631

Liège, 4000, Belgium

RECRUITING

Hopital Edouard Herriot /ID# 271142

Lyon, Auvergne-Rhône-Alpes, 69003, France

RECRUITING

CHU Brest - Hôpital de la Cavale Blanche /ID# 271114

Brest, Brittany Region, 29200, France

RECRUITING

CHU Toulouse - Hôpital Rangueil /ID# 271138

Toulouse, Occitanie, 31400, France

RECRUITING

Hopital de la Conception /ID# 271152

Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France

RECRUITING

Hopital Universitaire Necker Enfants Malades /ID# 271146

Paris, Île-de-France Region, 75015, France

RECRUITING

TUM Klinikum rechts der Isar /ID# 271522

Munich, Bavaria, 81675, Germany

RECRUITING

Medizinische Hochschule Hannover /ID# 270938

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Universitaetsklinikum Koeln /ID# 270937

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935

Berlin, 10117, Germany

RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563

Rome, Roma, 00161, Italy

RECRUITING

Hokkaido University Hospital /ID# 271385

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

National Hospital Organization Kyoto Medical Center /ID# 271782

Kyoto, Kyoto, 612-8555, Japan

RECRUITING

Juntendo University Hospital /ID# 271722

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 272022

Chiba, 260-8712, Japan

RECRUITING

Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247

Dordrecht, South Holland, 3318 AT, Netherlands

RECRUITING

Lumc /Id# 271844

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen /ID# 271249

Groningen, 9713 GR, Netherlands

RECRUITING

Unidade Local de Saude de Almada-Seixal, EPE /ID# 271257

Almada, Setúbal District, 2805-267, Portugal

RECRUITING

2CA-Braga, Hospital de Braga /ID# 271258

Braga, 4710-243, Portugal

RECRUITING

Unidade Local de Saude do Algarve, EPE /ID# 271819

Faro, 8000-386, Portugal

RECRUITING

Unidade Local de Saude de Sao Jose, EPE /ID# 271255

Lisbon, 1150-199, Portugal

RECRUITING

Unidade Local de Saude de Lisboa Ocidental, EPE /ID# 271261

Lisbon, 1449-005, Portugal

RECRUITING

Pusan National University Hospital /ID# 271429

Busan, Busan Gwang Yeogsi, 49241, South Korea

RECRUITING

Keimyung University Dongsan Hospital /ID# 272455

Daegu, Gyeongsangbuk-do, 42601, South Korea

RECRUITING

Seoul National University Hospital /ID# 271331

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

SMG-SNU Boramae Medical Center /ID# 271227

Seoul, Seoul Teugbyeolsi, 07061, South Korea

RECRUITING

Hallym University Kangnam Sacred Heart Hospital /ID# 271329

Seoul, Seoul Teugbyeolsi, 07441, South Korea

RECRUITING

Hospital Universitari de Bellvitge /ID# 270489

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Fundacio Puigvert /ID# 270491

Barcelona, 08025, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves /ID# 270918

Granada, 18014, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz /ID# 270485

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre /ID# 270829

Madrid, 28041, Spain

RECRUITING

Hospital Clínico Universitario de Valencia /ID# 270837

Valencia, 46010, Spain

RECRUITING

Related Publications (1)

• Cortinovis M, Perico N, Remuzzi G. The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care. Clin J Am Soc Nephrol. 2025 Dec 5. doi: 10.2215/CJN.0000000975. Online ahead of print.

  PMID: 41348481 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: March 30, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

IT (1); PT (5); US (35); AU (4); BE (3); FR (5); DE (4); NL (3); KR (5); ES (6); JP (4)