[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)

[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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051250034

Enrollment

Registered

2025-05-30

Start date

2025-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

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

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
-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.	—

Measure

Time frame

-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.

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Countries

Australia, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Portugal, South Korea, Spain, United States of America

Contacts

Public ContactContact for Patients and HCP

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026