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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06902558
Registration number
NCT06902558
Ethics application status
Date submitted
25/03/2025
Date registered
30/03/2025
Date last updated
9/09/2025
Titles & IDs
Public title
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)
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Scientific title
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)
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Secondary ID [1]
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2024-517143-31-00
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Secondary ID [2]
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M25-147
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autosomal Dominant Polycystic Kidney Disease
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-CLS-628
Treatment: Drugs - Placebo
Experimental: ABBV-CLS-628 Dose A - Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
Experimental: ABBV-CLS-628 Dose B - Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
Experimental: ABBV-CLS-628 Dose C - Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
Placebo comparator: Placebo - Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
Treatment: Drugs: ABBV-CLS-628
IntraVenous Infusion
Treatment: Drugs: Placebo
IntraVenous Infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
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Assessment method [1]
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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).
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Timepoint [1]
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Week 96
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Primary outcome [2]
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Number of Participants with Adverse Events (AEs)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 118 weeks
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Secondary outcome [1]
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Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
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Assessment method [1]
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eGFR will be measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).
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Timepoint [1]
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Week 96
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Secondary outcome [2]
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Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
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Assessment method [2]
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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).
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Timepoint [2]
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Week 48
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Secondary outcome [3]
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Absolute Change in eGFR From Baseline
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Assessment method [3]
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eGFR will be measured using the CKD-EPI Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).
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Timepoint [3]
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Week 48
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Secondary outcome [4]
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Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR
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Assessment method [4]
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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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Timepoint [4]
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Up to Week 96
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/06/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2029
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital /ID# 271224 - Brisbane
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Florida
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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Belgium
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Brussels Capital
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Japan
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State/province [9]
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Kyoto
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Japan
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Tokyo
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Japan
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State/province [11]
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Chiba
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Country [12]
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Netherlands
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State/province [12]
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South Holland
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Portugal
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State/province [13]
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Braga
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Portugal
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State/province [14]
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Faro
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Portugal
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State/province [15]
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Lisbon
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Country [16]
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Spain
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State/province [16]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Calico Life Sciences LLC
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Address [1]
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Ethics approval
Ethics application status
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Summary
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 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.
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Trial website
https://clinicaltrials.gov/study/NCT06902558
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
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Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06902558
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