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To Assess the Efficacy and Safety of Utilizing Galactose-deficient IgA1 Biomarker Changes to Guide Pathogenic IgA-targeted Therapeutic Strategies

RecruitingNAAges 18 Years - 75 YearsAllHong Zhang
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female, between 18 and 75 years age; * Biopsy confirmed diagnosis of primary IgA nephropathy or IgA Vasculitis-Associated Nephritis; * Persistent proteinuria, defined as: two separate measurements (with an interval of โ‰ฅ 4 weeks) of 24-hour urinary protein excretion (24hUTP) โ‰ฅ 0.5 g/day, or urine protein-to-creatinine ratio (UPCR) โ‰ฅ 0.44 g/g; * Estimated glomerular filtration rate (eGFR) (CKD-EPI) โ‰ฅ 30 ml/min per 1.73m\^2; * Have received the angiotensin converting enzyme Inhibitors(ACEI) / angiotensin receptor blocker(ARB) standard treatment for 4 weeks prior to randomization; * Intending to receive or having received Nefecon or telitacicept treatment for โ‰ค 2 weeks at the time of screening. Exclusion Criteria: * Secondary IgA nephropathy (excluding IgA vasculitis) caused by ankylosing spondylitis, systemic lupus erythematosus, viral hepatitis, liver cirrhosis, etc.; * With a known history or clinical evidence of concurrent renal diseases other than IgA nephropathy; * Treating with systemic corticosteroids or immunosuppressants including cyclophosphamide, azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, rituximab, etc. within 3 months prior to randomizing; * Have initiated or had a dose adjustment of leflunomide, tripterygium wilfordii or hydroxychloroquine within 3 months prior to randomizing; * Active tuberculosis or latent carrier without treatment; * Herpes zoster infected patients or patients with positive HIV antibody, positive HCV antibody or HBV infection (According to the HBV screening test, a) the HBsAg-positive; b) HBsAg-negative and HBcAb-positive, the HBV-DNA should be tested to determine the situation: the HBV-DNA positive subjects should be excluded, while the HBV-DNA negative subjects can participated in.) * Suffering from following gastrointestinal diseases: gastric ulcer bleeding within the past 6 months, active inflammatory bowel disease, a history of major gastrointestinal surgery (e.g., gastrectomy, gastroenterostomy, or bowel resection), or pancreatic injury/pancreatitis within the past 6 months; * A confirmed history of osteoporosis or osteonecrosis of the femoral head; * Type 1 or type 2 diabetes with poor glycemic control (HbA1c \> 8%); * Body mass index (BMI) \< 18.5 kg/mยฒ.; * Systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg; * Decreased lymphocyte count (absolute value \< 1.1 ร— 10โน/L) or decreased immunoglobulin G (IgG \< 6 g/L). * Hepatic dysfunction, meeting any of the following: a) Child-Pugh Class C liver dysfunction; b) ALT or AST \> 2 ร— upper limit of normal (ULN), or total bilirubin \> 2 ร— ULN at screening; c) history of hepatic encephalopathy, esophageal varices, or portosystemic shunt surgery; * Evidence of urinary tract obstruction or dysuria. * A history of solid organ transplantation, hematopoietic stem cell/cell/bone marrow transplantation, or kidney transplantation. * Pregnancy, lactation, female participants with childbearing plans during the trial or within 6 months of its completion, and male participants planning to conceive or donate sperm during the trial or within 3 months of its completion; * With a history of malignant tumors within the past 5 years (excluding cutaneous squamous cell carcinoma or basal cell carcinoma); * Allergy to human-derived biologics; * Nephrotoxic drugs is unavoidable during the study period; * Not suitable for the study judged by investigator.
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What it tests

  • Gd-IgA1 monitoring
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Where

1 site
Peking University First Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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