Glomerular disease is a type of kidney disease in which the part of your kidneys that helps filter waste and fluids from the blood is damaged.
Programs + Services
The Tufts MC Kidney and Blood Pressure Center provides both one-time consultations and ongoing care for chronic or acute kidney disease and high blood pressure.
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Research + Clinical Trials
The purpose of this clinical trial is to see if the drug atrasentan is safe and effective in treating IgAN, FSGS, DKD, and Alport Syndrome.
The study is comprised of an optional pre-screening period, screening, treatment, and follow-up periods. If you qualify, you will receive the study drug Atrasentan for up to 1 year.
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Primary Objectives:
• Evaluate the safety and tolerability of sparsentan oral suspension
• Assess changes in proteinuria after once-daily dosing of sparsentan oral suspension over the 108-week treatment period
Secondary Objectives:
• Assess the pharmacokinetics (PK) of sparsentan oral suspension in a pediatric population
• Assess changes in estimated glomerular filtration rate (eGFR) after once-daily dosing of sparsentan oral suspension over the 108-week treatment period
Exploratory Objective:
• Assess the palatability and acceptability of sparsentan oral suspension
Primary Endpoints:
• Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to treatment discontinuation, and adverse events of interest (AEOIs)
• Change from baseline in urine protein/creatinine ratio (UP/C) over the 108-week treatment period
Secondary Endpoints:
• Observed plasma PK concentrations at scheduled timepoints and visits
• Steady-state PK parameters (area under the plasma concentration-time curve during a dosing interval [AUCτ], maximum steady-state plasma drug concentration during a dosage interval [Cmax_ss], and minimum steady-state plasma drug concentration [Cmin_ss]) derived from population PK analysis
• Change from baseline in urine albumin/creatinine ratio (UA/C) over the 108-week treatment period
• Change from baseline in eGFR over the 108-week treatment period
• The proportion of subjects with focal segmental glomerulosclerosis (FSGS) and/or minimal change disease (MCD) histological patterns achieving partial remission, defined as UP/C ≤1.5 g/g and >40% reduction in UP/C over the 108-week treatment period
More information about research and clinical trials
