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)

Launched by ABBVIE · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called ABBV-CLS-628 for adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD), a genetic condition that causes fluid-filled cysts to grow in the kidneys. The study aims to find out how safe and effective this treatment is compared to a placebo (a treatment that looks the same but has no active medicine). About 240 participants will be involved, and they will be divided into four groups, where each group will receive different treatments, including the possibility of getting the placebo.

To participate, individuals must have a specific type of ADPKD and a certain level of kidney function. They should be between 18 and 75 years old and not currently receiving other treatments for ADPKD. During the trial, participants will receive infusions of ABBV-CLS-628 or placebo every four weeks for nearly two years and will have regular check-ups to monitor their health, including blood tests and questionnaires to assess any side effects. It’s important to note that participating in this trial may involve more visits and testing than usual care for ADPKD.

Gender

ALL

Eligibility 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.