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"An Early Phase 1, Exploratory Study Evaluating Diffusion Magnetic Resonance Imaging to Assess Baseline Differences Between Adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and Healthy Subjects, and Disease Progression in Adults with ADPKD”
Rochester, Minn.
The purpose of this study is to assess the ability of 18F-sodium fluoride positron emission tomography ( 18F-NaF PET)/computed tomography (CT) and Diffusion magnetic resonance imaging (MRI) to differentiate between healthy subjects and ADPKD subjects at baseline
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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)
Rochester, Minn.,
Jacksonville, Fla.
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.
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A Study to Determine the Prevalence and Clinical Characteristics Associated With PKD1 Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to estimate the prevalence of PKD1 gene variant groups in the ADPKD population and describe the demographic and clinical characteristics of ADPKD by PKD1 gene variant group.
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