Intravenous ABBV-CLS-628 for adults with autosomal dominant polycystic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with ADPKD (Mayo Class 1C–1E) and an eGFR of 30–90 mL/min/1.73 m^2 are randomized into one of four treatment arms to receive intravenous ABBV-CLS-628 or placebo approximately every 4 weeks for 92 weeks. About 240 participants are expected to enroll across roughly 100 sites worldwide, with follow-up visits for safety and efficacy monitoring for up to 15 weeks after dosing ends. The study records adverse events and measures of kidney function and disease progression to compare outcomes across dose groups and placebo. Participation requires regular clinic or hospital infusion visits, which may be more burdensome than routine care.

Why it matters

Who can join: the full rules

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.

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Valiance Clinical Research - Huntington Park
  Huntington Park, California, United States Recruiting
• Academic Medical Research Institute (AMRI) - Los Angeles
  Los Angeles, California, United States Recruiting
• UC Irvine Medical Center
  Orange, California, United States Recruiting
• National Institute of Clinical Research - Pomona
  Pomona, California, United States Recruiting
• University Of California, San Francisco
  San Francisco, California, United States Recruiting

+41 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Calico Clinical Trial Communication
• Email: clinicaltrialcommunication@calicolabs.com
• Phone: 650-754-6200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.