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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)
NCT06902558 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ABBV-CLS-628
Study Locations (20)
Florida
- Horizon Research Group - Coral Gables /ID# 270857 — Coral Gables
- South Florida Research Institute /ID# 270848 — Fort Lauderdale
- Nature Coast Clinical Research - Inverness /ID# 270875 — Inverness
- Mayo Clinic Hospital Jacksonville /ID# 271011 — Jacksonville
- Panax Clinical Research /ID# 270851 — Miami
- Infigo Clinical Research /ID# 270844 — Sanford
California
- National Institute of Clinical Research - Garden Grove /ID# 271418 — Garden Grove
- Valiance Clinical Research - Huntington Park /ID# 270634 — Huntington Park
- Academic Medical Research Institute - Los Angeles /ID# 270502 — Los Angeles
- UC Irvine Medical Center /ID# 270811 — Orange
- University Of California, San Francisco /ID# 270326 — San Francisco
Idaho
- CARE-Boise Kidney /ID# 270628 — Boise
- CARE Institute - Idaho Falls /ID# 272005 — Idaho Falls
Massachusetts
- Tufts Medical Center /ID# 270323 — Boston
- Beth Israel Deaconess Medical Center /ID# 271408 — Boston
Connecticut
- Yale University School of Medicine /ID# 270675 — New Haven
Georgia
- Emory University School Of Medicine - Atlanta /ID# 271947 — Atlanta
Illinois
- Northwestern University Feinberg School of Medicine /ID# 271409 — Chicago
Iowa
- University of Iowa /ID# 270492 — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2025-06-09 |
| Est. Completion | 2029-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06902558
The ClinicalTrials.gov registry entry for NCT06902558 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Autosomal Dominant Polycystic Kidney Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06902558 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06902558 about?
NCT06902558 is a clinical study titled "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)". 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...
What is the current status of trial NCT06902558?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2025-06-09. Estimated completion is 2029-08.
What conditions does trial NCT06902558 study?
This clinical trial studies the following conditions: Autosomal Dominant Polycystic Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06902558?
The interventions under investigation include: Placebo (DRUG), ABBV-CLS-628 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06902558?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06902558 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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