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A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 12 Weeks of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD) (ARPKD)
Rochester, Minn.
The primary objective of this study is to evaluate the effect of tolvaptan on the need for renal replacement therapy in pediatric subjects with autosomal recessive polycystic kidney disease (ARPKD).
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A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Rochester, Minn.
The purpose of this study is to evaluate the safety of tolvaptan in pediatric subjects with autosomal recessive polycystic kidney disease (ARPKD).
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Assessing the Accuracy of Measuring Total Kidney Volume and Characterizing Kidney Cysts in Children with Autosomal Dominant Polycystic Kidney Disease Using Three-Dimensional Ultrasound and Deep Learning Approaches
Rochester, Minn.
The purpose of this study is to assess the accuracy of three-dimensional ultrasound (3D US) in measuring total kidney volume (TKV) in children with autosomal dominant polycystic kidney disease (ADPKD). We will obtain MR-based measurements of TKV as the goal standard by which we will evaluate the accuracy of the 3D US based measurements.
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Childhood ADPKD Database Study
Rochester, Minn.
The purpose of this study is to expand the currently limited knowledge about Autosomal Dominant Polycystic Kidney Diseases (ADPKD) by creating a registry of clinical information about this set of diseases.
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Urinary crystal burden as a biomarker for predicting disease progression in pediatric patients with autosomal dominant polycystic kidney disease (ADPKD)
Rochester, Minn.
The purpose of this study is to characterize urinary crystalluria, supersaturation, cytokines, and extracellular vehicles from activated renal tubular epithelial cells, interstitial monocytes, and pro-and anti-inflammatory macrophages in a cohort of male and female pediatric patients with autosomal dominant polycystic kidney disease (ADPKD). Also, to determine cross-sectional associations between cyst burden/kidney function and urinary crystalluria, supersaturation, cytokines, and extracellular vehicles (EVs).
Closed for Enrollment
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Comparing mGFR and eGFR in Pediatric ADPKD: A Pilot Study
Rochester, Minn.
The purpose of this study is to compare measured glomerular filtration rate (mGFR) using Iothalamate, a gold standard marker, with various creatinine (Cr)-based and cystatin (Cys)-based estimated GFR (eGFR) calculations in pediatric patients with autosomal dominant polycystic kidney disease (ADPKD). Also, to determine the level of agreement between mGFR and different eGFR equations in pediatric patients with ADPKD.
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