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 the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants. ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide. Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
IntraVenous Infusion
IntraVenous Infusion
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGValiance Clinical Research - Huntington Park
Huntington Park, California, United States
RECRUITINGAcademic Medical Research Institute (AMRI) - Los Angeles
Los Angeles, California, United States
RECRUITINGUC Irvine Medical Center
Orange, California, United States
Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
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).
Time frame: Week 96
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to approximately 118 weeks
Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
eGFR will be measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).
Time frame: Week 96
Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
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).
Time frame: Week 48
Absolute Change in eGFR From Baseline
eGFR will be measured using the CKD-EPI Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).
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
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.
Time frame: Up to Week 96
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National Institute of Clinical Research - Pomona
Pomona, California, United States
RECRUITINGUniversity Of California, San Francisco
San Francisco, California, United States
RECRUITINGUniversity of California Los Angeles Medical Center
Santa Monica, California, United States
NOT_YET_RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGHorizon Research Group - Coral Gables
Coral Gables, Florida, United States
WITHDRAWNSouth Florida Research Institute
Fort Lauderdale, Florida, United States
RECRUITING...and 81 more locations