A Phase 2 interventional study of ABBV-CLS-628 and Placebo in Autosomal Dominant Polycystic Kidney Disease, sponsored by Calico Life Sciences LLC. Recruiting at 91 sites in 12 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Calico Life Sciences LLC · Phase 2, Interventional, and Treatment
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.
185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.
This study's planned enrollment of 240 is above the median of 51 across 138 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.
Browse Polycystic Kidney, Autosomal Dominant studies →Calico Life Sciences LLC is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.
Drug: ABBV-CLS-628
Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.
Drug: ABBV-CLS-628
Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.
Drug: ABBV-CLS-628
Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.
Drug: Placebo
IntraVenous Infusion
IntraVenous Infusion
Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
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).
Time frame: Week 96
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to approximately 118 weeks
Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
eGFR will be measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).
Time frame: Week 96
Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)
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).
Time frame: Week 48
Absolute Change in eGFR From Baseline
eGFR will be measured using the CKD-EPI Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).
Time frame: Week 48
Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR
Defined as initiation of renal replacement therapy (RRT) or kidney transplantation, or a confirmed decline in eGFR of 40% or more from baseline, sustained for at least 4 weeks.
Time frame: Up to Week 96
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Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Polycystic Kidney, Autosomal Dominant →
Calico Life Sciences LLC