Idiopathic membranous nephropathy
Conditions
Interventions
Experimental group:Taking the traditional Chinese medicine - Yishen Kangyan Formula
Control group:None
Sponsors
Xi'an Jiaotong University Second Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-70 years; 2.Diagnosed as idiopathic membranous nephropathy (IMN) by renal biopsy or positive for anti-phospholipase A2 receptor (PLA2R) antibody detected by chemiluminescent immunoassay; 3.Estimated glomerular filtration rate (eGFR) > 60 mL/min per 1.73 m^²; 4.Meeting the definition of moderate-to-high risk group in the KDIGO guidelines (eGFR 8 g/day for more than 6 months; or normal eGFR with proteinuria > 3.5 g/day, and the reduction in proteinuria is no more than 50% within 6 months after treatment with angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB)); 5.Conforming to the syndrome of blood stasis internal obstruction in traditional Chinese medicine (TCM); 6.Having signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Secondary membranous nephropathy; i) White blood cell (WBC) count 2.5 times the normal range, and total bilirubin > 1.5 times the normal range); 7.Known hypersensitivity or contraindications to any component of the study drugs; 8.Patients who are pregnant, lactating, or unwilling to take contraceptive measures; 9.White blood cell (WBC) count < 3×10^?/L or CD4? cell count < 200 cells/µL; 10.Having received treatment with traditional Chinese medicine-containing drugs or biological agents within 1 month before enrollment; 11.Life-threatening nephrotic syndrome or a sharp decline in renal function that cannot be explained by other causes;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement rate of TCM efficacy indicators in patients with idiopathic membranous nephropathy (IMN) at 12th month;The immunological response rate of idiopathic membranous nephropathy (IMN) patients at 12th month;The total effective rate of proteinuria remission in idiopathic membranous nephropathy (IMN) in 12th month;The disease recurrence status of idiopathic membranous nephropathy (IMN) patients within 12 months after the initiation of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total remission rate, recurrence, improvement of TCM syndromes, and immunological response at 3, 6, and 9 months; as well as the proportion of patients with a serum creatinine increase > 50% and e; | — |
Countries
China
Contacts
Public ContactRongguo Fu
Xi'an Jiaotong University Second Affiliated Hospital
Outcome results
None listed