Podocytopathies
Conditions
Interventions
1:Tacrolimus monotherapy
2:Tacrolimus combined with glucocorticoids
Sponsors
Department of Nephrology, Qianfoshan Hospital, Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Male or female patients, ageing 18-65yr; 3. Clinical diagnosis of nephritic syndrome( urine protein>3.5 g/d, serum albumin 30ml/min (CKD-EPI equation); 7. Glucocorticoids and other immunosuppressants were not used within 3 months.
Exclusion criteria
Exclusion criteria: 1. No informed consent, or unable or unwilling to meet the requirements of the protocol; 2. Secondary nephritic syndrome (malignance, drugs, etc); or / and interstitial fibrosis >50%; 3.Used prednisone, MMF, tacrolimus, CsA and other drug treatment within 3 months of screening, and the course of treatment was more than 4 weeks. Or used cyclophosphamide (cumulative dose >1.0g); 4.Patients known to be allergic to tacrolimus, prednisone, or any intergrant of these drugs; 5. Patients with HBV serum indicators positive (HbsAg or/and HbeAg or/and HbcAb), HCV positive or liver dysfunction (ALT/AST or Bil above twice the normal value, last more than 2weeks); 6.Patients diagnosed with diabetes (defined as FBS >=7.0 mmol/L or diabetes symptoms + RBS >=11.1 mmol/L or 2h PBS>=11.1 mmol/L) or impaired glucose tolerance (2h PBS 7.8–11 mmol/L); 7.Patients with history of pancreatitis or gastrointestinal ulcer and/or gastrointestinal bleesing during last 6 monthes; 8. Patients with history of congenital or acquired immunodeficiency, or combined with active tuberculosis/active CMV infections, or serious infections requiring intravenous antibiotics; 9.Patients with other sever physical or mental diseases; 10.Patients with history of congenital heart diseases, arhythmia, heart failure or other severe cardiovascular diseases; 11. Female patients: pregnant or breast feeding or unwilling to take adequate contraception during the study; 12. Patients participated in other clinicl trials during last 3 months; 13. Other medical or social reasons for exclusion at the discretion of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24hr urine protein;serum albumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| estimated glomerular filtration rate;liver function;routine blood test;routine urine test;plasma concentration of TAC; | — |
Countries
China
Contacts
Public ContactDongmei Xu
Department of Nephrology, Qianfoshan Hospital, Shandong University
Outcome results
None listed