membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome
Conditions
Interventions
CyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks
CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks
Sponsors
Project team for treatment of refractory nephrotic syndrome
The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The subject's urine protein excretion is more than 3.5g/day and serum albumin level is less than 3.0g/dL before the treatment. In addition, corticosteroids treatment for more than 4 weeks has not reduced the subject's urine protein excretion into less than 1g/day before the study commencement. 2) Before registration, membranous nephropathy or focal segmental glomerulosclerosis is diagnosed by renal biopsy. 3) The subject has never been treated with CyA-MEPC before registration. 4) The subject has voluntarily signed a document of the informed consent.
Exclusion criteria
Exclusion criteria: 1) The subject presents with renal dysfunction (Ccr less than 50mL/min or serum creatinine more than 2mg/dL). 2) The subject has been treated with other immunosuppressants within one month prior to the study commencement. 3) The subject should be treated with nephrotoxic or hyperkalemic agents during the study period. 4) The subject has a malignant tumor, or had a recurrent malignant tumor previously. 5) The subject has hypertension uncontrolled with antihypertensive drugs. 6) The subject has malabsorption syndrome, cerebral dysfunction or epilepsy. 7) The subject has hyperkalemia or hyperuricemia. 8) The subject has a severe cardiac, hepatic or pancreatic disease. 9) The subject is currently pregnant, is supposed to be pregnant, or is nursing. 10) The subject has an infectious complication and is not available for the treatment with Immunosuppressants. 11) The subject previously had hypersensitivity to CyA-MEPC. 12) The subject is inappropriate for participation in the study as determined by an investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urine protein excretion (g/day) remission status of nephrotic syndrome | — |
Secondary
| Measure | Time frame |
|---|---|
| renal function(creatinine clearance(Ccr)) serum total protein and albumin levels serum total cholesterol level | — |
Countries
Japan
Contacts
Public ContactTakao Saito
Project team for refractory nephrotic syndrome Division of Nephrology and Rheumatology, Fukuoka University Hospital
Outcome results
None listed