AbbVie M25-147 Study

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)

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Polycystic kidney disease
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All genders
person-wave 18-55
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Overview
Principal Investigator: Craig Gordon, MD

The study is being conducted to access the safety and efficacy of the study drug ABBV-CLS-628 in people that have Autosomal Dominant Polycystic Kidney Disease (ADPKD). Details of the study visit are explained below

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Olaniyi Ogunbodede

Study details
Inclusion Criteria
  • Must be 18 to 55 years of age, and willing to provive a written informed consent.
  • Must have ADPKD Class 1C, 1D, or 1E bases on the Mayo Clinic Imaging Classification
  • Must have eGFR ≥ 30 mL/min/1.73 m2 and < 90 mL/min/1.73 m2, using theCKD-EPI equation at Screening
Exclusion Criteria
  • Patients on current interventions to treat ADPKD such as non-approved medications or lifestyle medication.
  • Patients who had recent renal sugery within the last 6 months prior to screening.
  • Patients with Renal Replacement Therapy.
Study Requirements

If you agree to join, you will be in the study for approximately up to 114 weeks, which include Screening period of approximately 45 days, Study Treatment Period of approximately 96 weeks, and a Follow-up call 15 weeks (105 days after the last dose of the study drug. You will be randomly assigned (like tosing a coin) to receive either the study drug or placebo ( inactive drug). There will be 3 dose groups of ABBV-CLS-628 and 1 placebo group. All subjects will receive every 4 weeks IV administration for 1 of 3 ABBV-CLS-628 doses or Placebo. During the study, you will have tests done at several times, including Abdomonal MRI, Bone Density Scan Fand Hearing test, as well as having blood drawn. The volume of blood collected will depend on the visit