Personalized IgA Nephropathy treatment guided by Gd-IgA1 monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized trial compares two patient groups: one in which Gd-IgA1 levels are measured regularly to adjust therapy, and another where these measurements are not used to guide treatment. All participants have progressive IgA-related kidney disease and are treated with Nefecon or telitacicept while standard care continues. The goal is to see if dynamic biomarker-guided treatment can improve kidney outcomes and safety compared with traditional management. Biomarker monitoring may enable earlier adjustments before traditional markers show change. The study is conducted at Peking University First Hospital in Beijing with a single lead sponsor and no listed collaborators.

Why it matters

Who can join: the full rules

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 ≥ 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 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/m².;
* Systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg;
* 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;
* 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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yunfei Bao
• Email: baoy_fei@163.com
• Phone: 086-18500228190

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.