Status:
RECRUITING
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)
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Calico Life Sciences LLC
Conditions:
Autosomal Dominant Polycystic Kidney Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06902558
Start Date
June 9 2025
End Date
August 1 2029
Last Update
January 2 2026
Active Locations (66)
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1
National Institute of Clinical Research - Garden Grove /ID# 271418
Garden Grove, California, United States, 92844
2
Valiance Clinical Research - Huntington Park /ID# 270634
Huntington Park, California, United States, 90255
3
Academic Medical Research Institute - Los Angeles /ID# 270502
Los Angeles, California, United States, 90022
4
UC Irvine Medical Center /ID# 270811
Orange, California, United States, 92868-3201