Idiopathic membranous nephropathy Urological and Genital Diseases
Conditions
Interventions
1. Treatment regimen: The patients will be randomly assigned into one of the two groups: steroid + TAC group (P + T group) or TAC alone group (T group), and observed for 24 weeks.
Patients in the P +
the dose will be tapered 2 weeks after the patient has achieved clinical remission, at a rate of 5 mg/d every 2 weeks
once the dose has been reduced to 10 mg/d, the dose will be tapered at a rate of 2.5 mg/d every two weeks until withdrawal
for patients who fail to achieve clinical remission within 4 weeks, the dose will be tapered as described above.
Patients in the T group will receive TAC 0.05 mg/kg/d (two doses per day, morning and
Sponsors
The First Affiliated Hospital of Zhengzhou University (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with idiopathic membranous nephropathy confirmed by renal biopsy (light microscopy + SEM) 2. Clinical manifestations of nephrotic syndrome 3. Persistent serum creatinine < 115 mmol/L or the reference value of creatinine 4. Any age group, male or female
Exclusion criteria
Exclusion criteria: 1. Secondary MN with hepatitis or malignant tumor 2. Use of steroids, cytotoxic drugs, or immunosuppressants within 3 months of this study 3. Other severe organ diseases 4. Fasting blood glucose > 6.2 mmol/L or confirmed diabetes 5. Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in 24-hour urine protein from baseline and percent change 2. Change in serum albumin from baseline and percent change Measured at baseline, 2, 4, 8, 12, 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in serum creatinine and eGFR from baseline and percent changes 2. Change in serum PLA2R antibodies from baseline Measured at baseline, 2, 4, 8, 12, 24 weeks. | — |
Countries
China
Outcome results
None listed