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Completed

NCT Number: NCT01162005

Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

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.

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Key information

Conditions

Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

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

Other names: Trcrobell

Primary outcomes

  1. Remission Rate

    Time frame: 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 outcomes

  1. Duration of Remission

    Time frame: 12-month treatment period

    Mean duration of remission

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Chong Kun Dang Pharmaceutical

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 14, 2010
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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