44 Clinical Trials for Various Conditions
The ASSIST study is a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy (IgAN) while on background standard of care therapy and an SGLT2 inhibitor (SGLT2i).
The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice. The main question it aims to answer is: Is there a treatment benefit of TARPEYO® 16 mg QD extended use? Participants will * take part in this study for about 19 months * Have urine tests done * Have blood samples taken * Have physical examinations done
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
The ASSIST study is a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy (IgAN) while on background standard of care therapy and an SGLT2 inhibitor (SGLT2i).
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.
Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.
A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)
The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.
The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.
The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)
This is an open-label Phase 2a clinical study designed to evaluate the safety and efficacy of AVB-S6-500 in patients with IgA Nephropathy (IgAN). Approximately 24 patients will be enrolled. Several dose levels of AVB-S6-500 may be evaluated.
Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).
To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).
The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2 g/day) assessed at 36 weeks from baseline.
This main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria. The study hypothesis was that treatment with Atacicept would reduce proteinuria compared to placebo.
The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based on an improvement in proteinuria.
IgA nephropathy occurs when IgA-a protein that helps the body fight infections-settles in the kidneys. IgA deposits may cause the kidneys to leak blood and sometimes protein in the urine. Proteinuria (abnormal amounts of protein in urine) can be a sign of kidney damage. Current treatments for IgA nephropathy is limited to Angiotensin Converting Enzyme (ACE) inhibitor medications with fish oil. ACE Inhibitors, also called ACEI medications, slows the angiotensin converting enzyme so that blood vessels can be relaxed. This study involves the study drugs, Acthar and Lisinopril (an ACEI medication routinely given for high blood pressure). In previous clinical studies, some subjects with IgA nephropathy have experienced reductions in proteinuria with consistent use of Acthar. Acthar is approved by the Food and Drug Administration (FDA) and used to treat patients with proteinuria. The purpose is to study the safety and effectiveness of the study drug Acthar given at different doses.
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.
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy
The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to induce complete or partial remission in patients with severe IgA nephropathy. The secondary objectives are to assess clinical outcomes relating to safety and efficacy, such as infection, malignancy, preservation of renal function, partial responders, relapse rate, and to study mechanistic assays to predict remission.
This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine. Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.
IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements (FOS).
This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.
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 Imunoglobulin A Nephropathy (IgAN) and high risk of progression.
The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population.
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)
The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.