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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)
Jacksonville, Fla.,
Rochester, Minn.
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 Phase 2a, Open-label, Single-arm Study To Evaluate The Efficacy, Safety, And Pharmacokinetics Of VX-407 In Subjects With Autosomal Dominant Polycystic Kidney Disease Who Have A Subset Of PKD1 Gene Variants
Rochester, Minn.,
Jacksonville, Fla.
The purpose of the study is to evaluate the effect of VX-407 on height-adjusted total kidney volume (htTKV), safety, tolerability, and pharmacokinetics (PK) of VX-407.
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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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Concept Elicitation And Cognitive Debriefing Interviews To Explore The Signs, Symptoms And Impacts In Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this qualitative interview study is to explore adult participants’ experiences of living with Autosomal Dominant Polycystic Kidney Disease (ADPKD). This includes identifying signs, symptoms, and impacts of the disease that are relevant and most bothersome to these patients through concept elicitation (CE) interviews. This study also aims to assess the appropriateness of instruments for measuring symptom burden and impact in people with ADPKD through cognitive debriefing (CD) interviews. The instruments that will be debriefed in this study are planned to be included in a Phase 3 trial investigating the benefits of a novel once-monthly subcutaneous treatment to slow kidney function decline in adults at risk of rapidly progressing ADPKD.
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Exploratory analysis to identify biomarkers associated with Autosomal Dominant Polycystic Kidney Disease
Jacksonville, Fla.
The purpose of this study is to collect biological samples (whole blood and saliva) to develop and validate a genotype assay for Autosomal Dominant Polycystic Kidney Disease (ADPKD). Also, to determine the associations between genotype and ADPKD severity and/or progression, and to collect biological samples (blood and urine) to develop exploratory biomarker assays for potential correlation with ADPKD disease severity and/or progression.
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Urinary urate levels in patients with ADPKD
Jacksonville, Fla.
The purpose of this study is to assess the levels of urate in urine samples of patients with autosomal dominant polycystic kidney disease (ADPKD). Investigate how different urinary urate levels are associated with the severity of the disease and patients’ demographics, comorbidities, and treatments.
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Investigating The Performance Of Renasight In A Cystic Kidney Disease Clinic
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to analyze clinical, radiological, and genotypic data of a cohort of 384 patients with cystic kidney disease who underwent Renasight (Natera) genetic testing at Mayo Clinic (dataset will consist of patients from IRB# 13-003971 who consented have their information/samples stored and used in future research at Mayo Clinic or patients that participated in a previous study of the RenaCARE application (21-02744) and who orally consent to participate in this research (203), and those who had clinical testing with Renasight at Mayo Rochester (203) and Jacksonville (118)).
Closed for Enrollment
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A Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine Output and Increasing the Urine Osmolality in Patients with Hereditary Nephrogenic Diabetes Insipidus, Patients with Autosomal Dominant Polycystic Kidney Disease Treated with Tolvaptan, And Severely Polyuric Patients with Previous Lithium Administration (SerendipityPB1)
Jacksonville, Fla.
The objectives of this study are to evaluate the effectiveness and safety of PB in the treatment of patients with hereditary nephrogenic diabetes insipidus, to evaluate the effectiveness and safety of PB in polyuric patients with autosomal dominant polycystic kidney disease treated with tolvaptan, and to evaluate the effectiveness and safety of PB in polyuric patients previously treated with lithium.
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A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose and an Open-Label Fixed-Dose Study in Patients with Autosomal Dominant Polycystic Kidney Disease to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of
RGLS8429
Rochester, Minn.,
Jacksonville, Fla.
The purpose of ths study is to assess the safety and tolerability of RGLS8429. Addiitionally, to assess the impact of RGLS8429 on ADPKD biomarkers
Other objectives are o assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) and to characterize the pharmacokinetic (PK) properties of RGLS8429 -To assess the impact of RGLS8429 on renal function.
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