Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

This study has been withdrawn prior to enrollment.
Chong Kun Dang Pharmaceutical
Information provided by:
Seoul National University Hospital Identifier:
First received: July 12, 2010
Last updated: November 17, 2015
Last verified: July 2010

The use of tacrolimus in NS(nephrotic syndrome) has been reported in single and small series case reports. To determine the efficacy of tacrolimus in the management of NS, 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. 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.

Condition Intervention Phase
Nephrotic Syndrome
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Partial or complete Remission rate of Steroid resistant nephrotic syndrome [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total remission duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus Drug: Tacrolimus
dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year


Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Frequent relapse nephrotic syndrome
  • steroid resistance nephrotic syndrome

Exclusion Criteria:

  • secondary nephrotic syndrome
  • estimated GFR < 60 mL/min/1.73m2
  • with active hepatitis
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Please refer to this study by its identifier: NCT01162005

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Chong Kun Dang Pharmaceutical
  More Information

Responsible Party: Il Soo Ha, Seoul National University Hospital Identifier: NCT01162005     History of Changes
Other Study ID Numbers: INS-Tacrobell  INS-Tacrobell-Pediatrics 
Study First Received: July 12, 2010
Last Updated: November 17, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Primary Nephrotic syndrome

Additional relevant MeSH terms:
Nephrotic Syndrome
Kidney Diseases
Urologic Diseases
Calcineurin Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 30, 2016