To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the investigators designed this prospective study. The investigators will enroll 100 children with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents. Follow-up is every second week for the first 4 weeks, then monthly. After initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.
Subsequently , monthly measurements were made until stable levels of tacrolimus were achieved. Urine was analyzed for proteinuria at each visit. Serum creatinine, glucose, albumin and alanine aminotransferase were measured and complete blood counts were obtained at each visit during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year
Seoul National University Hospital
Seoul, South Korea
Remission Rate
Complete remission at 12 months Per KDIGO clinical practice guideline for glomerulonephritis (2012): Complete remission (CR), urine protein creatinine ratio below 200mg/g (20mg/mmol) or 1+ of protein on urine dipstick for 3 consecutative days
Time frame: 12-month treatment period
Duration of Remission
Mean duration of remission
Time frame: 12-month treatment period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.