Nephrotic syndrome
Conditions
Interventions
Treatment with prednisolone and Neoral.
Treatment with prednisolone alone.
Sponsors
Kyoto university hospital
Kyoto City Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with initial, frequent recurrent or steroid dependent Nephrotic Syndrome who are full filled following criteria. 1. Patients who are diagnosed as nephritic syndrome defined by the diagnosis criteria of nephritic syndrome authorized by MHLW 2. Patients who are 18 to 75 years old in principle. 3. Patients who are either outpatients or hospitalization. 4. Patients who have not taken any cyclosporine products 5. Patients who have written consent to participate in this study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients who meet following criteria will be excluded from this study. 1. Patients with renal impairment that is defined as that creatinin clearance is less than 50ml/min calculated from serum creatinin and from pooled urine creatinin. 2. Patients who are diagnosed as a steroid resistant nephrotic syndrome. 3. Patients who have to take any drugs, which have renal toxicity. 4. Patients with malignancy or history of malignancy. 5. Patients who have uncontrollable hypertension by any treatment. 6. Patients with malabsorption syndrome, cerebral circulatory disturbance or seizure 7. Patients with cardiac, liver or pancreatic severe disease 8. Patients who are pregnancy, lactation or suspicion of pregnancy. 9. Patients who are considered that immunosuppressive drugs should not be used due to infection. 10. Patients who have an episode of allergic reaction to any ingredients of Neoral. 11. Patients who are judged ineligible to enroll into this trial due to any reasons by the study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine protein (mg/day) | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission Frequency of Recurrence Duration of hospitalization Cumulative dose of corticosteroid Creatinine Clearance Serum Creatinine Serum albumin Total protein (serum) Total cholesterol (serum) Edema | — |
Countries
Japan
Contacts
Public ContactNoriyuki Iehara
kyoto university hospital Nephrology section
Outcome results
None listed