Podocytosis
Conditions
Interventions
Experimental group:Prednisone + Tacrolimus
The control group:Prednison
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form. 2. Patients between the ages of 18 and 65 years of age, of either sex. 3. Patients with 24-hour urine protein quantification > 0.5 g/d and serum creatinine values in the normal range or elevated, but eGFR not less than 30 ml/( min-1.73m2 ). 4. Eligible to undergo renal puncture biopsy and exclude contraindications related to renal puncture biopsy.
Exclusion criteria
Exclusion criteria: 1. Failure to sign a written informed consent or inability or unwillingness to comply with the investigator-approved study protocol. 2. Secondary nephrotic syndrome (tumor, drugs, etc.). 3. Patients with known hypersensitivity to tacrolimus, glucocorticoids, or to any of the components of the above drugs. 4. Patients with positive HBV serological indicators (HBsAg or/and HBeAg), HCV positive patients or patients with abnormal liver function (ALT, AST or bilirubin above normal). AST or bilirubin exceeds 2 times or more the upper limit of normal value and remains elevated for 2 weeks). 5. Patients with congenital or acquired immunodeficiency, or co-infection with active TB, active CMV, etc. Combined with severe Patients with severe infections requiring intravenous antibiotics. 6. A clear history of peptic ulcer and/or gastrointestinal bleeding within 6 months. 7. Patients with other serious physical or mental illnesses, as well as patients with congenital heart disease, cardiac arrhythmia, heart failure, and other serious cardiovascular diseases. Patients with serious cardiovascular disease. 8. Female patients who are pregnant, breastfeeding or unwilling to use contraceptive measures. 9. Patients who have participated in other clinical trials within three months prior to enrollment. 10. Patients whose condition is judged by the investigator to be unsuitable for participation in this trial study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proteinuria remission rate;Renal biopsy pathological results;Blood PLA2R antibody assay;Blood THSD7R antibody assay;Blood fixed immunoglobulin electrophoresis assay;urine fixed immunoglobulin electrophoresis assay;Blood free Light chain assay;Urinary free light chain assay; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tacrolimus blood levels;Blood creatinine;Serum albumin;Blood Count;Urine Routine; | — |
Countries
China
Contacts
Public ContactZhou Zhu
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed