Summary

Eligibility
for people ages 18-55 (full criteria)
Location
at Orange 5379513, California 5332921 and other locations
Dates
study started
study ends around

Description

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.

Official 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)

Keywords

Autosomal Dominant Polycystic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease (ADPKD), ABBV-CLS-628, Autosomal Dominant Polycystic Kidney

Eligibility

You can join if…

Open to people ages 18-55

  • 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 m2 and < 90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening.

You CAN'T join if...

  • 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.

Locations

  • UC Irvine Medical Center /ID# 270811 accepting new patients
    Orange 5379513 California 5332921 92868-3201 United States
  • National Institute of Clinical Research - Garden Grove /ID# 271418 accepting new patients
    Garden Grove 5351515 California 5332921 92844 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT06902558
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated