Primary Membranous Nephropathy
Conditions
Interventions
Experimental group:Telitacicept + background basic therapy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with primary MN confirmed by renal biopsy; 2.(Patients who failed RTX treatment, defined as those whose anti-PLA2R antibody titer did not decrease by >=50% or whose urine protein level did not decrease by >=50% after 3 months of RTX treatment; 3.Patients with an estimated glomerular filtration rate (eGFR) >=30 mL/min/1.73m^2 at the time of enrollment.
Exclusion criteria
Exclusion criteria: 1. It is known that there are allergic reactions or contraindications to any planned drug (such as glucocorticoids) or any of the components of the above-mentioned drugs; 2. There is a history of allergic reactions to contrast agents, human or murine proteins, or monoclonal antibodies used outside the intestine; 3. Have received any of the following treatments: a. Have received tumor bad death factor inhibitors, interleukin receptor blockers, or other small molecule or biological agents (including belimumab) within 12 weeks prior to screening or within 5 half-lives of the drug (whichever is longer); b. Patients who have received any clinical trial drugs within 60 days before baseline or within 5 half-lives (whichever is longer), etc. 4. There are major, unstable or poorly controlled acute or chronic diseases (such as cardiovascular, lung, blood, digestive tract, liver, kidney, nervous system, malignant tumor or infectious diseases) that the researchers believe may affect the research results or pose excessive risks to patients, which are not caused by MN. 5. Plan to undergo surgery or have any disease, laboratory abnormality or condition that the researcher deems unsuitable for participation in the trial; 6. Pregnant women, lactating women, and men or women who have plans to have children during the trial period; 7. A history of malignant tumors within the past five years, except for well-treated skin cancer (basal cell carcinoma or squamous cell carcinoma) or cervical carcinoma in situ; 8. Suffering from acute or chronic infections that require treatment; 9.HIV antibody positive; 10. Hepatitis B 11. Positive for hepatitis C antibody; 12. Those with a positive test result indicating a COVID-19 infection within 4 weeks before screening, or those with a severe history of COVID-19 who need hospitalization within 12 months before screening; 13. Renal biopsy shows more than 50% glomerular sclerosis; 14. Patients whom the researchers considered unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-PLA2R antibodies; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine protein quantification, eGFR, CD19? B cells, serum BLyS/APRIL levels; | — |
Countries
China
Contacts
Public ContactJin Shang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed