Clinical Research Directory

MYTP01 for Immune-Mediated Diseases

The goal of this study is to evaluate whether MYTP01, a traditional Chinese herbal formula developed by clinical experts with the assistance of artificial intelligence (AI), is effective and safe as an additional treatment for immune-mediated diseases (post-kidney transplantation, IgA nephropathy, etc.). The study also aims to explore whether MYTP01 may provide therapeutic benefits across these conditions by regulating shared immune and inflammatory processes. The main questions this study aims to answer are: * Does MYTP01 provide clinical benefits and remain safe when used as an additional treatment for immune-mediated conditions? * Does MYTP01 help regulate immune balance and inflammatory responses across immune-mediated disease populations? Researchers will compare MYTP01 with a matching placebo, with both treatments given in addition to standard medical care, to evaluate clinical efficacy, safety, and potential immunomodulatory effects across immune-mediated conditions. Participants will: * Be enrolled in a disease-specific cohort based on their clinical condition. * Be randomly assigned to receive either MYTP01 or placebo in addition to their usual medical treatment. * Take the assigned study treatment twice daily for 8 weeks. * Attend follow-up visits approximately once a month during a 12-week study period. * Undergo clinical assessments, blood and urine tests, and evaluations of immune function and possible side effects.

A Study of JADE101 in Participants With Immunoglobulin A Nephropathy

This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in participants with IgA nephropathy, and the results will contribute to the overall clinical characterization of JADE101 in this patient population.

Phase 2b Open-Label Repeat Kidney Biopsy Study

Assess impact of sibeprenlimab on IgA deposition and other histological endpoints in kidney tissue at Week 52 relative to baseline

A Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants

The goal of this clinical trial is to evaluate the effect of food (a high-fat, high-calorie meal) on the PK of a single oral dose of budesonide delayed release tablet in healthy participants. The main questions it aims to answer are : (1) Does a high-fat, high-calorie meal significantly alter the plasma exposure (Cmax, AUC) of budesonide following oral administration of D23A? ( 2) How does food intake affect the absorption rate (Tmax, Tlag) and other PK parameters of D23A? Researchers will compare the plasma PK parameters of D23A administered under fasted conditions versus fed conditions to see if a high-fat, high-calorie meal has a significant impact on the bioavailability and absorption kinetics of D23A . Participants will receive a single oral dose of 16 mg D23A (4 tablets) in each period of the crossover study, with one period under fasted conditions and the other under fed conditions (after consuming a high-fat, high-calorie meal) . The study will also monitor and record any adverse events (AEs) to evaluate the safety and tolerability of D23A under fed conditions .

Serum and Urinary sCD163 in IgA Nephropathy

IgA nephropathy is a common primary glomerular disease with a highly variable clinical course. Soluble CD163 is a marker associated with monocyte and macrophage activation and may reflect inflammatory activity in kidney disease. This single-center observational study aims to evaluate the associations of serum and urinary soluble CD163 levels with clinical disease activity, histopathologic severity, and renal prognosis in patients with IgA nephropathy. Clinical, laboratory, and kidney biopsy findings will be assessed together with serum and urinary soluble CD163 measurements. Participants will also be followed for renal outcomes, including changes in kidney function and proteinuria. The study is expected to clarify whether soluble CD163 may serve as a noninvasive biomarker of disease activity and prognosis in IgA nephropathy.

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN

A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \<18 years with primary immunoglobulin A nephropathy (IgAN).

Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)

This Phase 3, open-label study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of sibeprenlimab administered subcutaneously every 4 weeks in pediatric participants aged 2 to 17 years with IgA nephropathy (IgAN). Sibeprenlimab will be administered as an add-on to standard of care therapy consisting of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs).

Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study

immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity. In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced. One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group). Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study.

Atacicept in Subjects With IgA Nephropathy

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G

A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)

A Phase IIa Study in Primary IgA Nephropathy Patients

This is a phase IIa, multicenter, single-arm, open-label study to evaluate the safety and efficacy of XH-S003 in patients with primary IgA nephropathy

Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy

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

IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients at recruited hospitals and developing a IgAN database in China. Patients will be follow-up every one year, and both baseline and follow-up information will be entered into the registration system. All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN database.

Correlation of Microbiome and Metabonomics With IgA Nephropathy

IgAN is the most prevalent primary glomerulonephritis in China, is characterized by the deposition of IgA1 (particularly, galactose-deficient IgA1) in the glomerular mesangium. Galactosedeficient IgA1, supposed to be produced by Peyer patches in the mucosa-associated lymphoid tissue (MALT), is triggered by exposure to commensal or pathogenic bacteria, involved in the initial step in the pathogenesis of IgAN. Similar to intestinal flora, a disruption in oral flora is closely associated with the occurrence of many malignant tumors and autoimmune diseases. The relationship between oral and throat microflora and the occurrence of IgAN is unclear at present. The aim of the present study was to develop a preliminary model based on mucosa -specific microbes and clinical indicators to facilitate the early diagnosis of IgAN and obtain insights into its treatment.

Efficacy and Safety of Mycophenolate Mofetil in Refractory IgA Nephropathy

This study is testing whether a medicine called mycophenolate mofetil (MMF) works better than the usual treatment for people whose kidney disease, called IgA nephropathy, has not improved with standard care. IgA nephropathy is a kidney disease that can cause protein to leak into the urine and, over time, can damage the kidneys. Some people with this disease do not get better even after standard treatment. Doctors call this "refractory" disease. Right now, there is no proven best treatment for these patients in Bangladesh. This study will include 116 adults with kidney disease that has been confirmed by a kidney tissue sample and has not improved with standard treatment. Participants will be split into two equal groups by chance, like a coin flip. One group will take MMF by mouth for 6 months, along with the usual supportive care. The other group will take a steroid medicine called prednisolone, along with the usual supportive care. Both groups will also continue treatments like blood pressure medicines that are already part of standard care for this condition. Researchers want to find out how many people in each group get better, meaning their urine protein drops to a low level and their kidney function stays stable. They will also look at changes in kidney function and any side effects from the medicines. The study will take place at the National Institute of Kidney Diseases and Urology Hospital in Dhaka, Bangladesh, over about one year. Each participant will be followed for 6 months, with check-up visits and blood and urine tests at the start, at 3 months, and at 6 months.

The Chinese Registry of Prognostic Study of IgA Nephropathy (CRPIGA)

1. Establish an IgAN cohort collaboration group and expert committee to carry out registration research. 2. Construct IgAN structured data set standards, formulate structured data collection templates of diagnosis and treatment , and establish multi-center data integration systems on this basis. 3. Establish a standardized IgAN database for combined Hospital Information System and the big data platform of the Medical Federation. 4. Develop IgAN database managements and open standards for data sharing, and carry out high-quality clinical or basic research.

A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.

An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN, SSc, and IIM).

Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy

The ASSIST study was 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).

TESTING -ON Post-Trial ObservatioNal Cohort Study

The primary aim of this study is to extend follow up of TESTING study participants and to assess the long-term effects of a 6-9-month course of oral methylprednisolone on End Stage Kidney Disease (ESKD), according to dose (full-dose vs reduced-dose), ethnicity (Chinese vs other) and kidney function (eGFR above and below 60 mL/min/1.73m2).

Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis

The project is to explore in humans the hypothesis of the link between the alteration of tubulo-interstitial metabolism and the rate of deterioration of renal function by comparing various nephropathies.

Study of BHV-1400 in IgA Nephropathy

The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).

Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)

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).

A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy

The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.

Atrasentan in Patients With IgA Nephropathy

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.