IgA Nephropathy (IgAN)

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.

This is a Phase IIIb, multicenter, two-arm, randomized, double-blind, parallel group study to evaluate the efficacy and safety of zigakibart + atrasentan compared to zigakibart + placebo in patients with primary IgAN at risk of disease progression.

This multicenter, single-arm, open-label Phase 4 pilot study evaluates the effects of atrasentan added to optimized supportive care on kidney structure and function in adults with biopsy-confirmed IgA nephropathy. Approximately 20 participants will receive atrasentan 0.75 mg orally once daily for 52 weeks. Kidney multiparametric MRI is performed at baseline, 6 months, and 12 months, with blood and urine biomarker assessments throughout treatment. An optional nested cohort of up to 5 participants undergoes native kidney biopsy at baseline and 12 months.

The goal of this open-label, randomized study is to evaluate the efficacy and safety of the personalized treatment model in which Gd-IgA1 is dynamically monitored to guide medication adjustment in progressive IgAN patients treated with Nefecon or telitacicept. Researchers will compare two groups of participants: those who have Gd-IgA1 checked regularly during treatment, and those who do not. This is to find out if regular Gd-IgA1 checks can help doctors adjust medication better and get better treatment results.

This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase. In the dose-escalation phase, approximately 9-18 adult participants with immune-mediated kidney diseases are planned to be enrolled and treated with GT719 universal cell injection. The objectives of this phase are to evaluate the safety and tolerability of the product, determine the recommended dose (RD) for subsequent studies, conduct a preliminary assessment of its clinical efficacy, and investigate the pharmacokinetic and pharmacodynamic characteristics. Upon completion of the dose-escalation phase, after evaluation by investigators and collaborators, an appropriate dose will be selected for the dose-expansion phase. An additional 12 participants will be enrolled to fully assess the safety and efficacy of the product.

This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.

IgA nephropathy (IgAN) is a chronic progressive kidney disease, and long-term control of proteinuria and prevention of relapse are crucial for delaying disease progression. Patients with IgAN who achieve proteinuria remission after receiving Nefecon for 9 months or longer still face the risk of proteinuria relapse after treatment discontinuation. This study is to evaluate the efficacy and safety of Nefecon 8 mg treatment for 15 months as a maintenance therapy to reduce the risk of IgAN relapse in proteinuria-remitted patients.

This is an investigator initiated, single-arm, open-label, dose-escalation study to explore the preliminary efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection which is a CD19 and BCMA bispecific CAR-T cells in patients with autoimmune kidney diseases. Approximately 10-24 adult participants diagnosed as IgA nephropathy and primary membranous nephropathy will be enrolled. Three dose levels (1.5 E6 STAR-T cells/kg, 3.0 E6 STAR-T cells/kg and 4.5 E6 STAR-T cells/kg) will be established in this study, and the universal STAR-T cell will be administered as a single intravenous infusion. A recommended dose will be selected for subsequent dose-expansion studies to evaluate the safety and efficacy of universal STAR-T cell injection in participants with autoimmune kidney diseases based on the safety, PK results, and preliminary efficacy data. This study includes the screening period (D-28 to D-6), pre-clearance treatment and observation period (D-5 to D-1), cell infusion and main study endpoint observation period (D0 to W12 after infusion), and extended follow-up period (W12 to W104).

This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at \~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.

IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide, characterized by glomerular mesangial IgA deposits, often with IgG and C3. Despite its prevalence, the pathophysiology of IgAN is poorly understood. The prognosis varies significantly, from benign hematuria to rapidly progressive glomerulonephritis, potentially leading to end-stage renal disease within months. The MEST-C classification enhances prognosis characterization and informs integrated scoring systems; however, while useful for assessing overall prognosis, these scores do not reliably predict treatment responses and are unvalidated for IgA vasculitis nephritis. Given the disease's heterogeneity, treatment options for IgAN, with or without vasculitis, are controversial. Nephroprotective strategies that lower intraglomerular pressure through RAS blockade are essential in managing IgAN. Steroids are considered for rapidly progressive cases, yet their effectiveness in persistent proteinuria despite optimized nephroprotection is debated. Other immunosuppressive therapies, such as B cell targeting and complement inhibition, are under investigation. Recently developed nephroprotective strategies, including SGLT2 inhibitors and endothelin-1 receptor antagonists, may significantly influence future therapeutic approaches. Although available in many European countries, their real-world effectiveness has not been evaluated. Identifying factors linked to persistent proteinuria and renal dysfunction despite optimized nephroprotection is a critical unmet need. We hypothesize that innovative nephroprotective strategies will reduce the risk of persistent proteinuria and renal dysfunction in an IgAN cohort.

The goal of this observational study is to learn about loin pain in people with Immunoglobulin A nephropathy (IgAN). The main question it aims to answer is: What changes occur in the kidneys, urine, and blood when people with IgAN experience loin pain? Participants will have MRI scans of their kidneys, provide urine and blood samples, and have their latest kidney function test results reviewed. For participants who experience loin pain, these assessments will be carried out during a pain episode and again when they are pain-free, so the results can be compared.

This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.

Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN

This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard "3+3" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .

An observational study tracking the clinical course of patients with IgA nephropathy.

This study is a randomized, parallel, double-blind, placebo-controlled, subcutaneous administration Phase II dose-exploration clinical trial aimed at evaluating the efficacy, safety, PK, PD, and immunogenicity characteristics of SLN12140 at different doses in IgA nephropathy subjects who have previously received standard treatment (the standard treatment drugs allowed in this study include: angiotensin-converting enzyme inhibitors \[ACEi\], angiotensin II receptor blockers \[ARB\], and sodium-glucose co-transporter 2 inhibitors \[SGLT2i\]) but have poor control. The study is divided into four stages, including a screening period of up to 8 weeks, an introduction period of up to 12 weeks, a 40-week double-blind period (including a 36-week treatment period and a 4-week safety follow-up period; all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will enter the open-label extension period for continued treatment after completing the double-blind period), and a 56-week open-label extension period (all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will continue SLN12140 at the same dose group \[the optimal dose\], including a 52-week open treatment period and a 4-week safety follow-up period).

This study is a single-arm, single-center, open-label, dose-escalation exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of CD19 CAR-γδ T cells. The subjects enrolled in this study are patients with relapsed/refractory autoimmune nephropathy, including lupus nephritis, IgA nephropathy, and membranous nephropathy. This study adopts a standard "3+3" design to assess the recommended dose (RD) and identify dose-limiting toxicities (DLTs). The treatment process is as follows: subjects who meet the inclusion criteria will receive lymphodepletion conditioning, followed by a single intravenous infusion of CD19 CAR-γδ T cells. The primary objective of this study is to evaluate the safety profile of this cellular therapy, including the incidence of DLTs, maximum tolerated dose (MTD) or RD, as well as the incidence and severity of treatment-related adverse events and clinically significant abnormal laboratory test results after CAR-γδ T cell infusion (including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)). The planned follow-up duration of this study is 1 years.

This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard "3+3" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .

This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous injection of RG002C0106 between trial participants with normal renal function and those with mild to moderate renal impairment.

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.

The goal of this clinical trial is to learn if Shenqi Yishen Granules works to treat IgA Nephropathy in adults. It will also learn about the safety of Shenqi Yishen Granules. The main questions it aims to answer are: Does Shenqi Yishen Granules lower 24-hour urinary protein quantification of participants? What medical problems do participants have when taking Shenqi Yishen Granules? Researchers will compare Shenqi Yishen Granules to a placebo (a look-alike substance that contains no drug) to see if Shenqi Yishen Granules works to treat IgA Nephropathy.

To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.

This study looks at how well and safely RG002C0106 works for patients with certain kidney disease: primary IgA nephropathy. It's a phase IIa trial done at several locations where both patients and doctors unknow what treatment is being given.

This clinical trial is a prospective, multicenter, non-randomized controlled study designed to evaluate the efficacy and safety of Telitacicept, a novel biologic agent, in treating pediatric IgA Nephropathy (IgAN) and IgA Vasculitis Nephritis (IgAVN). The study plans to enroll 124 children aged 5-18, divided into a test group (standard therapy + Telitacicept) and a control group (standard therapy alone), with a 24-week treatment period. The primary endpoint is the change in 24-hour urine protein levels at week 24, while secondary outcomes include UPCR (urine protein-to-creatinine ratio), eGFR, and drug safety.

: IgA-nephropathy is the most common glomerulonephritis with the unfavorable prognosis in patients with persistent albuminuria. Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist that has demonstrated efficacy in reducing albuminuria in patients with CKD and type 2 diabetes in two major trials, FIGARO-DKD and FIDELIO. This finding supported the approval of finerenone by the U.S. Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD). A subgroup analysis in the pooled FIDELITY trial demonstrated that in patients with CKD stages 1-4 and type 2 diabetes (T2D), the cardio- and nephroprotective effects of finerenone were independent of concomitant therapy with SGLT-2 inhibitors or GLP-1 receptor agonists. Thus, the role of finerenone in slowing CKD progression in T2D can be considered well-established. Given its albuminuria-reducing effects, finerenone is being investigated in multiple trials, including studies on non-diabetic kidney disease and IgA nephropathy, though no published results are available yet. In this trial finerenone will be used as a nephroprotective agent above standard treatment in terms of assessing adverse events and potential efficacy.