Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Nephrotic Syndrome

Treatments: Drug: Tacrolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01162005

INS-Tacrobell-Pediatrics (Other Identifier)

INS-Tacrobell

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

Tacrolimus

Experimental group

Description:

Tacrobell

Treatment:

Drug: Tacrolimus