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Clinical Studies
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A multi-center open-label trial evaluating the efficacy and safety of daratumumab SC in treatment of patients with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to assess the effectiveness of daratumumab SC in treating patients with monoclonal immunoglobulin deposits (PGNMID) by assessing improvement in proteinuria at 12 months.
Additionally, to assess the safety of daratumumab SC in treating patients with PGNMID by assessing the incidence of major infections, eye complications, and cytopenias.
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A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to evaluate the efficacy and safety of Avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic IgAN and high risk of progression.
Closed for Enrollment
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A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd) (Nefigard)
Jacksonville, Fla.
The purose of this study is to evaluate the effectiveness, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).
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An Adaptive, Randomized, Double-blind, Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2 Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in Combination With Standard-of-care With and Without Oral Corticosteroids in Patients With Active Lupus Nephritis Class III-IV, +/- V
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the effectiveness, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment in Participants With Active Lupus Nephritis Class III-IV, +/- V.
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An Open-Label Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression
Jacksonville, Fla.,
Rochester, Minn.
This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function.
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DialySafe Device LED Light Assessment for Transillumination (DialySafe)
Jacksonville, Fla.
The purpose of this research is to gather information on the effectiveness of an innovative device called the “DialySafe” intended to help reduce the chance of needle infiltrations during hemodialysis procedures. The DialySafe concept is a light-based device intended to make the AV fistula and graft easily visible for needle insertion. Light is generated from a red LED embedded in the surface of the device. The device will use transillumination technology to visualize the access, which consists of shining light directly into the skin where blood absorbs some of the light, resulting in a true representation of the location of the vein.
The primary objective of this specific research is to evaluate and adjust the location, angle, type of the LED light placement in DialySafe device to achieve acceptable visibility of fistula or graft. It is important to note that the needle itself will not be inserted using this device under this research protocol.
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