IgA nephropathy after renal transplantation
Conditions
Interventions
original regimen (immunosuppressant + hormone):The drug was administered once a week for a total of 24 times.
Taiai 160mg group + original regimen (immunosuppressant + hormone), original regimen (immunosuppressant + hormone):The drug was administered once a week for a total of 24 times.
Taiai 240mg group + original regimen (immunosuppressant + hormone), :The drug was administered once a week for a total of 24 times.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily sign informed consent; 2) Patients with recurrent IgA nephropathy after renal transplantation; 3) Age =18 years old, =70 years old, male or female; 4) During the screening period, 24-hour urinary protein =0.75g/24h; 5) Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) >35mL/min per1.73m2; 6) Subjects had received a baseline treatment regimen including ACEI/ARB drugs for 12 weeks prior to randomization, and the dose of ACEI/ARB drugs (within the maximum tolerance range) was stable during the 4 weeks prior to randomization.
Exclusion criteria
Exclusion criteria: 1) Patients with malignant tumors; 2) Pregnant and lactating women and men or women who have a family plan during the trial; 3) The use of nephrotoxic drugs cannot be avoided during the trial; 4) Allergic to human biological products; 5) Patients deemed unsuitable for the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in urinary protein at 24 hours at week 24 compared to baseline.;the change of UPCR and/or UACR;the change of Urine Red Blood Cell Count;the change of IgA,IgG,IgM, C3,C4,B cells;the change of BLyS and April ; | — |
Secondary
| Measure | Time frame |
|---|---|
| the change of eGFR; | — |
Countries
China
Contacts
Public ContactWenjun Shang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed