Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

Phase 4

Completed

• Conditions: Nephrotic Syndrome
• Interventions: Drug: Tacrolimus

• Registration Number: NCT01162005
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-14
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Results First Submitted: 2016-11-12
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-05
• Last Update Submitted: 2018-09-05
• Results First Posted: 2019-02-07
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Frequent relapse nephrotic syndrome
• steroid resistance nephrotic syndrome

Exclusion Criteria

• secondary nephrotic syndrome
• estimated glomerular filtration rate < 60 mL/min/1.73m2
• with active hepatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus	Tacrolimus	Tacrobell

Primary Outcome Measures

Name	Time	Method
Remission Rate	12-month treatment period	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

Secondary Outcome Measures

Name	Time	Method
Duration of Remission	12-month treatment period	Mean duration of remission

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of