AbbVie Clinical Trial
The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants.
Sponsor: AbbVie
Overview: 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.
Inclusion Criteria:
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Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD.
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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:
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Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.
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Any exclusionary medical diseases, disorders, or conditions as described in the protocol.
Additional inclusion/exclusion criteria may apply.
Contact:
Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: [email protected]
Locations:
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Los Angeles, California, US
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Coral Gables, Florida, US
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Inverness, Florida, US
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Miami, Florida, US
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Shelby, Michigan, US
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Bethlehem, Pennsylvania, US
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Chattanooga, Tennessee, US
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Knoxville Tennessee, US
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Arlington, Texas, US
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Kyoto-shi, Kyoto, Japan
Learn more button: https://clinicaltrials.gov/study/NCT06902558