Renal transplantion
Conditions
Interventions
Experimental group:Tetacip combined with standard anti-rejection treatment plan - Telitacicept 160mg subcutaneous injection qw
Control group:Glucocorticoid combined with standard anti-rejection treatment plan - metformin 0.8mg/kg.d oral qd
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Participants in kidney transplantation research aged 18-60; 2) Transplanted kidney biopsy confirmed that it is IgA nephropathy; 3) Men and women are not limited to gender; 4) 24-hour urine protein >=1.0g/24h; 5) eGFR (calculated by CKD-EPI formula) >35mL/min/1.73m2; 6) Receive optimal optimal support treatment including ACEI/ARB for 12 weeks; and ACEI/ARB has been titrated to the maximum tolerance dose for at least 4 weeks; 7) Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Combined rejection reactions, including acute or chronic fluid rejection, cellular or vascular rejection reactions; 2) Combined with polyomavirus nephropathy, or positive for serum and/or urine BK virus; 3) Secondary IgAN: such as allergic purpura nephritis, compulsory spondylitis, systemic lupus erythematosus, dry syndrome, Viral hepatitis, cirrhosis, rheumatoid arthritis, mixed connective tissue disease, nodular polyarteritis, nodular erythema, psoriasis, ulcerative colitis, Crohn's disease, tumor, AIDS, etc.; 4) Combined with other non-rejection-mediated kidney diseases: thrombotic microvascular disease; 5) Cardiovascular and cerebrovascular diseases occurred within 12 weeks, including: myocardial infarction, unstable angina pectoris, ventricular arrhythmia, heart failure (New York Heart Association grade II-IV), stroke. 6) Biological preparations have been used in the past 6 months: such as rituximab, ATG, C5a monoclona, etc. 7) Hormone shock therapy has been used in the past 3 months (the daily dose of Qiandisone exceeds 1mg/kg); 8) Abnormalities in blood routine: white blood cells 1.5ULN, transaminase >3ULN; 10) Pregnant, recently preparing for pregnancy, lactating women; 11) Those who have participated in other clinical trials in the past 6 months; 12) The researchers believe that there are other people who are not suitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urine protein;Serum albumin;Serum creatinine;Estimated glomerular filtration rate, EGFR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycated IgA1;B cell proliferation and activation; | — |
Countries
China
Contacts
Public ContactYunying Shi
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Outcome results
None listed