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ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT06902558

RecruitingPhase 2

Sponsor: Calico Life Sciences LLC

Conditions: Autosomal Dominant Polycystic Kidney Disease

Interventions: ABBV-CLS-628, Placebo

Countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (90)
  • Birmingham, Alabama, United States
  • Huntington Park, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Pomona, California, United States
  • San Francisco, California, United States
  • Santa Monica, California, United States
  • New Haven, Connecticut, United States
  • Coral Gables, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Inverness, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Sanford, Florida, United States
  • Atlanta, Georgia, United States
  • Boise, Idaho, United States
  • Idaho Falls, Idaho, United States
  • Chicago, Illinois, United States
  • Iowa City, Iowa, United States
  • Kansas City, Kansas, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Shelby, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • + 60 more on CT.gov