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[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)

[M25-147] 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)

Otani Tetsuya

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Recruiting

May. 30, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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.

-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.

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks.

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).

-Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline [Time Frame: Week 96]
-Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) [Time Frame: Week 48]
-Absolute Change in eGFR From Baseline [Time Frame: Week 48]
-Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR [Time Frame: Up to Week 96]
Defined as initiation of renal replacement therapy (RRT) or kidney transplantation, or a confirmed decline in eGFR of 40% or more from baseline, sustained for at least 4 weeks.

+81-75-641-9161

April. 23, 2025

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

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