Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children (NCT01162005) | Clinical Trial Compass
CompletedPhase 4
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
South Korea77 participantsStarted 2010-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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