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

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)

Phase 2 Interventional AbbVie · NCT06902558

This trial will test whether intravenous ABBV-CLS-628 given every 4 weeks is safe and helps adults with ADPKD.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorAbbVie Industry-sponsored
Locations75 sites (Garden Grove, California and 74 other locations)
Trial IDNCT06902558 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with ADPKD classified Mayo 1C–1E with eGFR 30–90 mL/min/1.73 m^2 who can attend regular IV infusion visits and are not using other investigational ADPKD treatments.

Not a fit: Patients with more advanced kidney failure (eGFR <30), those outside the Mayo 1C–1E classification, or people using excluded ADPKD interventions may not benefit from or be eligible for this treatment.

Why it matters

Potential benefit: If effective, ABBV-CLS-628 could slow cyst growth and help preserve kidney function in adults with ADPKD.

How similar studies have performed: Some approved and experimental therapies have slowed ADPKD progression in prior trials, but ABBV-CLS-628 itself is investigational and has not yet been proven effective for this condition.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Garden Grove, California and 74 other locations

+25 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Autosomal Dominant Polycystic Kidney DiseaseABBV-CLS-628
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.