minimal change disease in adults
Conditions
Interventions
Group A:Tacrolimus orally taken 0.5-1mg q12h for 36w, tape
Group B:prednisone orally taken for 36w, 1.0 mg/kg.d, tape
Sponsors
Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent; 2. Male or female patients, ageing 18-65yr; 3. Newly onset nephritic syndrome( urine protein>3.5 g/d, serum albumin600mL/d, or>1000mL/d after using diuretic drugs; 6. Serum creatinine (SCr)<=133mmol/L; 7. Female patients in child-bearing periond have negative urine pregnancy test,and willing to use adequate contraception.
Exclusion criteria
Exclusion criteria: Patents will be excluded if andy of the following criteria is present: 1. No informed consent, or unable or unwilling to meet the requirements of the protocol; 2. Secondary minimal change disease(malignance, drugs, etc) 3. Patients previously treated with steroid or other immunosuppressent (cyclophosphamide, cyclosporin, mycophe nolat mofetil); 4. 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); 5. Patients known to be allergic to tacrolimus, prednisone, or any intergrant of these drugs; 6. 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); 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; 9. Patients with other sever physical or mental diseases; 10. Patients with history of maliganacy during last 5 years; 11. Patients with history of congenital heart diseases, heart failure, arhythmia or other severe cardiovascular diseases; 12. Patients with history of sever infections in need of introvenous antibiotics; 13. Female patients: pregnant or breast feeding or unwilling to take adequate contraception during the study; 14. Patients participated in other clinicl trials during last 3 months; 15. Other medical or social reasons for exclusion at the discretion of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rates in 12w and the end of study; | — |
Secondary
| Measure | Time frame |
|---|---|
| weight and BMI;new-onset diabetes or abnormal glucose tolerance;Osteoporosis;Spiritual and psychological abnormalities;infection;morbidty of acute renal failure;life style quality changes;Renal biopsy pathological changes before and after treatment;Extra hospitalizations;time to achieve complete and partial remission;the proportion of patients with ineffective therap;recurrence;changes of kidney function;Centripetal obesity index;changes of kidney function; | — |
Countries
China
Contacts
Public ContactJianghua Chen
Outcome results
None listed