The effects of tonsillectomy and steroid pulse therapy in patients with IgA nephropathy : multicenter,radomized trial

UMIN ID: C000000384

Registered date:31/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: IgA nephropathy
• Date of first enrollment: 2005/04/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

combined therapy by tonsillectomy and steroid pulse therapy
steroid pulse therapy alone

Outcome(s)

• Primary Outcome: 1)change in 24-hour urinary protein excretion and the degree of microscopic hematuria from baseline, 2)percentage of patients with clinical remission, i.e., without proteinuria and hematuria
• Secondary Outcome: 1)change in creatinine clearance from baseline, slope of 1/serum creatinine vs. time 2)incidence of events (doubling of serum creatinine or 50% decrease in creatinine clearance from baseline and dialysis) 3)percentage of adverse effects

Key inclusion & exclusion criteria

• Age minimum: 10years-old
• Age maximum: 69years-old
• Gender: Male and Female
• Exclude criteria: 1)Patients with nephrotic syndorome 2)Patients whose serum creatinine is 1.6mg/dl or more 3)Patients who have been treated with steroid 4)Pregnant women or women of child bearing potential and nursing women. 5)Patients who can not be given anesthetic because of cardiac failure, respiratory failure or uncontrollable severe hypertension 6)Patients in whom tonsillectomy should not be done by the decision of otorhinolaryngologists because of the difficulty of tonsillectomy or no indication 7)Patients with hypersensitivity to the drugs used in the study 8)Patients who are judged to be inappropriate for the study by the investigator or subinvestigator

Related Information

• Primary Sponsor: Research Group for Tonsillectomy and Steroid Pulse therapy in IgA naphropathy
• Source(s) of Monetary Support: The Kidney Foundation, Japan