Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

NCT ID: NCT01162005

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-10-31

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.

Conditions

Nephrotic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus

Tacrobell

Group Type: EXPERIMENTAL

Tacrolimus

Intervention Type: DRUG

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

Interventions

Tacrolimus

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

Intervention Type: DRUG

Other Intervention Names

Trcrobell

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Il Soo Ha

Study chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ILSOO Ha, MD, PhD

Role: STUDY_CHAIR

Seoul National Children's Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

INS-Tacrobell-Pediatrics

Identifier Type: OTHER

Identifier Source: secondary_id

INS-Tacrobell

Identifier Type: -

Identifier Source: org_study_id