drugset / Trial / NCT01162005

Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

NCT01162005 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-07
Primary completion
2013-09
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.1 mg/kg —
Subject Tacrolimus Small molecule 0.2 mg/kg —

Indications