Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome

UMIN ID: C000000369

Registered date:27/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome
• Date of first enrollment: 2004/04/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: urine protein excretion (g/day) remission status of nephrotic syndrome
• Secondary Outcome: renal function(creatinine clearance(Ccr)) serum total protein and albumin levels serum total cholesterol level

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Project team for treatment of refractory nephrotic syndrome
• Secondary Sponsor: The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan
• Source(s) of Monetary Support: Japan Kidney Foundation