Filter Results
Clinical Studies
Results filtered:Study status:
Open
Contact Us for the Latest Status
Closed for Enrollment
Open
-
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.
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.
-
A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN). (SIRIUS-LN)
Jacksonville, Fla.
The purpose of this trial is to evaluate the effectiveness, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active Lupus Nephritis (LN).
-
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.
Contact Us for the Latest Status
-
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)
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.
-
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.
-
Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI) (REBOOT)
Jacksonville, Fla.
The primary objective of this study is to determine the effectiveness of belimumab with rituximab at inducing a complete or partial remission (CR or PR) compared to rituximab alone in patients with Primary Membranous Nephropathy (PM).
Closed for Enrollment
-
A Multi-Center Randomized Controlled Trial of Rituximab versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN) (MENTOR)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The primary outcome of this study is to determine whether or not the B cell targeting with Rituximab is more effective than Cyclosporine in inducing long term remission of proteinuria.
-
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the
Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the effectiveness and safety of LNP023 compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients.
-
A Multicentre International Randomized Parallel Group Double-blind Placebo-controlled Clinical Trial of EMPAgliflozin Once Daily to Assess Cardio-renal Outcomes in Patients With Chronic KIDNEY Disease (EMPA-KIDNEY)
Jacksonville, Fla.
The primary purpose of this study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease.
-
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy (Otsuka 417-201-00007)
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.
-
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN) - M-PLACE
Jacksonville, Fla.
The purpose of this study is to assess the safety and tolerability of MOR202 treatment in subjects with Antibody Positive Membranous Nephropathy (aMN).
-
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).
-
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease (Dapa-CKD)
Jacksonville, Fla.
The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease
-
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.
-
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.
-
Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT) (PRECISION)
Jacksonville, Fla.
The purpose of the study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.
.