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NCT06902558 · ClinicalTrials.gov registry record · Phase 2

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)

A Phase 2 study of Autosomal Dominant Polycystic Kidney Disease, sponsored by AbbVie.

Recruiting
Registry status
Phase 2
Development phase
240
Enrollment target
20
Study locations

NCT06902558: Recruiting Phase 2 study of Autosomal Dominant Polycystic Kidney Disease, sponsored by AbbVie.

NCT06902558 is a Phase 2 study of Autosomal Dominant Polycystic Kidney Disease that is actively recruiting participants, run by AbbVie. The registered enrollment target is 240 participants, above the 135-participant average among 9 other Autosomal Dominant Polycystic Kidney Disease trials with a reported enrollment target (78% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06902558, a Phase 2 study of Autosomal Dominant Polycystic Kidney Disease, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 2
Development phase
240 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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).

Conditions Studied

Autosomal Dominant Polycystic Kidney Disease

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

FieldValue
Enrollment Target 240 participants
Start Date 2025-06-09
Est. Completion 2029-08
Phase Phase 2
AbbVie

526 total trials

What NCT06902558 shows while recruiting

NCT06902558 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 9 other Autosomal Dominant Polycystic Kidney Disease trials with a reported enrollment target (78% higher).

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.

NCT06902558 names 20 study sites across 9 states, led by Florida, California, Idaho.

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.

What interventions are being tested in trial NCT06902558?

The interventions under investigation include: Placebo (DRUG), ABBV-CLS-628 (DRUG).

Who is sponsoring clinical trial NCT06902558?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Autosomal Dominant Polycystic Kidney Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06902558's enrollment target sits among peer trials

240 2nd of 9 the highest of 9 other Autosomal Dominant Polycystic Kidney Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autosomal Dominant Polycystic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06902558

Source: ClinicalTrials.gov NCT06902558, the US trial registry maintained by the National Library of Medicine. NCT06902558 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.