Conditions: Nephrotic Syndrome
Keywords: Primary Nephrotic syndrome
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 77
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Tacrobell

Interventions: intervention 1: Tacrolimus
Intervention descriptions: intervention 1: dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year

Protocol document: