Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Chong Kun Dang Pharmaceutical
• Treatments: Tacrolimus

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