idiopathic membranous nephropathy
Conditions
Interventions
Placebo group:Simulant of Yishen Huazhuo granules, 2 sachets each time, twice daily
Low dose group:Yishen Huazhuo granules and simulant, 1 sachet each, twice daily
High dose group:Yishen Huazhuo granules, 2 sachets each time, twice daily
Sponsors
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years; 2. Patients who meet the Western diagnosis of idiopathic membranous nephropathy with a clear pathological type of membranous nephropathy on previous renal puncture, or who have no previous renal puncture but are positive for anti-PLA2-R antibodies; 3. Those with evidence of spleen and kidney qi deficiency and blood stasis syndrome in traditional Chinese medicine; 4. Low risk populations with 24h urine protein quantification of 0.5 to 3.5g/d; 5. eGFR >= 60 ml/min/1.73m2 (calculated according to CKD-EPI formula); 6. Voluntarily participated in the study and signed an informed consent in a compliant process.
Exclusion criteria
Exclusion criteria: 1. Progressive degradation of renal function and renal biopsy showing severe tubulointerstitial lesions; 2. Plasma albumin 5.5 mmol/L; 4. Patients with comorbidities such as cardiovascular, gastrointestinal, endocrine, coagulation dysfunction and other serious primary diseases, or patients with poor glycemic control; 5. Patients with a concomitant disease of hepatitis and other underlying liver diseases and connective tissue diseases; 6. Patients with malignancy or a history of malignancy, psychiatric history or other inability to cooperate; 7. Screening for individuals who have received continuous treatment with glucocorticoids, immunosuppressants, cytotoxic drugs, or biologics for more than one month in the first six months; Screening for individuals who have received treatment with glucocorticoids, immunosuppressants, and cytotoxic drugs in the previous month; Screening for individuals who have received biologic therapy in the first 6 months; 8. Female patients who are pregnant, breastfeeding or have a pregnancy plan; 9. Patients who are allergic to the test drug and its excipients; 10. Those who have participated in other clinical trials within 30 days prior to screening; 11. Those who, in the judgment of the investigator, are not suitable for inclusion in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of 24-hour urine protein quantification from baseline;The change of serum albumin from baseline;The change of glomerular filtration rate (eGFR) from baseline;The proportion of patients who progress to be at medium and high risk;The change of the titer of the anti-phosphodiesterase A2 receptor antibody (anti-PLA2-R antibody) from baseline;the change of TCM Syndrome score from baseline;the efficacy on TCM Syndrome; | — |
Countries
China
Contacts
Public ContactYang Hongtao
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed