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)

Study Identifier
M25-147
CT.gov Identifier
NCT06902558
EudraCT Identifier
Not available
EUCTIS ID
2024-517143-31-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Kidney Disease
    • Study Drug
  • ABBV-CLS-628
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 55 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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.
    Exclusion Criteria:
    * Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications. * Any exclusionary medical diseases, disorders, or conditions as described in the protocol.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    National Institute of Clinical Research - Garden Grove /ID# 271418
    Garden Grove, California, United States, 92844
    Status
    Recruiting
    Location
    Valiance Clinical Research - Huntington Park /ID# 270634
    Huntington Park, California, United States, 90255
    Status
    Recruiting
    Location
    Academic Medical Research Institute - Los Angeles /ID# 270502
    Los Angeles, California, United States, 90022
    Status
    Recruiting
    Location
    UC Irvine Medical Center /ID# 270811
    Orange, California, United States, 92868-3201
    Status
    Recruiting
    Location
    University Of California, San Francisco /ID# 270326
    San Francisco, California, United States, 94143-2202
    Status
    Recruiting
    Location
    Yale University School of Medicine /ID# 270675
    New Haven, Connecticut, United States, 06510
    Status
    Recruiting
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