jRCT2051250034RecruitingNot Applicable
[M25-147] A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- AbbVie GK
- Enrollment
- 24
- Primary Endpoint
- Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 18age old over to 55age old under (—)
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.
Outcomes
Primary Outcomes
Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
Time Frame: Week 96
TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Secondary Outcomes
- Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR(Up to Week 96)
Investigators
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