Using Gd-IgA1 blood level checks to guide treatment in IgA nephropathy
Tests whether regular Gd-IgA1 checks help adjust medicines in adults with IgA nephropathy.
Plain-language title generated from the registry record
Registry title: To Assess the Efficacy and Safety of Utilizing Galactose-deficient IgA1 Biomarker Changes to Guide Pathogenic IgA-targeted Therapeutic Strategies
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07822100, who can take part
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hong Zhang
- Trial code
- NCT07822100
- Record updated
- 16 September 2026
- Original description
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.Read full original descriptionShow less
Development and Validation of a Gd-IgA1 Guided Precision Therapy System for Targeted Therapeutic Strategies of IgA Nephropathy： An Open-label, Random Controlled Trial
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.
Inclusion: 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 ≥ 4 weeks) of 24-hour urinary protein excretion (24hUTP) ≥ 0.5 g/day, or urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g; Estimated glomerular filtration rate (eGFR) (CKD-EPI) ≥ 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 ≤ 2 weeks at the time of screening.
Exclusion: 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; Nephrotoxic drugs is unavoidable during the study period; Secondary IgA nephropathy (excluding IgA vasculitis) caused by ankylosing spondylitis, systemic lupus erythematosus, viral hepatitis, liver cirrhosis, etc; 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; A history of solid organ transplantation, hematopoietic stem cell/cell/bone marrow transplantation, or kidney transplantation; 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; Type 1 or type 2 diabetes with poor glycemic control (HbA1c > 8%); Decreased lymphocyte count (absolute value < 1.1 × 10⁹/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 × upper limit of normal (ULN), or total bilirubin > 2 × ULN at screening; c) history of hepatic encephalopathy, esophageal varices, or portosystemic shunt surgery; Body mass index (BMI) < 18.5 kg/m²; Systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg; Evidence of urinary tract obstruction or dysuria; 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; Not suitable for the study judged by investigator.