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ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

RecruitingPhase 2Ages 18 Years - 55 YearsAllCalico Life Sciences LLC
NCT06902558 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 . P

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📋 Eligibility rules (as published)
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.
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What it tests

  • ABBV-CLS-628
  • Placebo
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Where

91 sites
University of Alabama at Birmingham
Birmingham, United States
Valiance Clinical Research - Huntington Park
Huntington Park, United States
Academic Medical Research Institute (AMRI) - Los Angeles
Los Angeles, United States
UC Irvine Medical Center
Orange, United States
National Institute of Clinical Research - Pomona
Pomona, United States
University Of California, San Francisco
San Francisco, United States
University of California Los Angeles Medical Center
Santa Monica, United States
Yale University School of Medicine
New Haven, United States

…and 83 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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