IgA nephropathy
Conditions
Interventions
Sponsors
Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary lgA nephropathy confirmed by renal biopsy; 2. Proteinuria (last examination): >=1.0g/d at the maximum tolerated dose of RAS block: - The latest laboratory examination >=1.0g/d at visit 1. - >= 1.0g/d when receiving the maximum tolerated dose of RAS block at visit 2; 3. eGFR(last check)>=30 ml/min PER1.73 m. Diagnosis of lgA nephropathy will be marked by direct immunofluorescence or immunohistochemical examination of lgA deposition; - There is no other reason to explain this nephropathy. - Serum creatinine and urine protein were assessed at least twice during the screening period. - Calculate the estimated GFR using the CKD-EP equation. 4. Aged 18-75 years old.
Exclusion criteria
Exclusion criteria: 1. Indications for the need for corticosteroid immunotherapy, such as: With IgA sedimentary tiny lesions of kidney disease; Over the past 12 months, more than 50% in renal biopsy in glomerulus crescent; 2. Other indications for immunosuppressive therapy, such as calcineurin inhibitors, cyclophosphamide, or mycophenolate mofel; 3. Systemic immunosuppressive therapy for the past 6 months; 4. Nephrotic syndrome or crescentic nephritis: 5. Malignant/uncontrolled hypertension (systolic blood pressure & GT;160mmHg or diastolic blood pressure & GT;110mmg); 6. A history of malignancy in the past 5 years, excluding treated non-melanoma skin cancer (i.e. Squamous or basal cell carcinoma); 7. Other causes of current renal instability, such as acute kidney injury due to massive hematuria (past events are not excluded); 8. Secondary IgA disease, such as lupus erythematosus, cirrhosis, and purpura; 9. Obvious liver disease.For example,ALT levels are 2.0 times higher than the upper normal limit (ULN), or total bilirubin is 1.5 times higher than ULN; 10. Current or planned pregnancy or breastfeeding; 11. Active systemic infection or severe infection during the first month of enrollment, including HIV, hepatitis C virus, hepatitis B virus; 12. White blood cell count & LT; 3.0x10^9/L, anemia (hemoglobin level below 80g/L), platelet count below 80x10^9/L, or other blood diseases; 13. Prolonged QT interval or severe arrhythmia on electrocardiogram; 14. Medications that can prolong the QT interval if taken at the same time; 15. Evidence of active peptic ulcer disease or a reliable history of gastrointestinal bleeding in the past five years; 16. Apparent cardiac insufficiency; 17. Cognitive impairment; 18. Patients whom the competent physician considers unable to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uroprotein quantification;eGFR; | — |
Countries
China
Contacts
Public ContactJingwei Zhou
Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine
Outcome results
None listed