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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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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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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.
Closed for Enrollment
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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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