Clinical Trial: Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

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 Summary: 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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: Partial or complete Remission rate of Steroid resistant nephrotic syndrome [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Total remission duration [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: July 12, 2010
Date Started: July 2010
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016