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Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01162005
First Posted: July 14, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Il Soo Ha, Seoul National University Hospital
  Purpose

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.


Condition Intervention Phase
Nephrotic Syndrome Drug: Tacrolimus Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

Resource links provided by NLM:


Further study details as provided by Il Soo Ha, Seoul National University Hospital:

Primary Outcome Measures:
  • Partial or complete Remission rate of Steroid resistant nephrotic syndrome [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Total remission duration [ Time Frame: 2 years ]

Enrollment: 80
Study Start Date: July 2010
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus
Tacrobell
Drug: Tacrolimus
dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year
Other Name: Trcrobell

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162005


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Chong Kun Dang Pharmaceutical
Investigators
Study Chair: ILSOO Ha, MD, PhD Seoul National Children's Hospital
  More Information

Responsible Party: Il Soo Ha, Study chair, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01162005     History of Changes
Other Study ID Numbers: INS-Tacrobell
INS-Tacrobell-Pediatrics ( Other Identifier: Seoul National University Hospital )
First Submitted: July 12, 2010
First Posted: July 14, 2010
Last Update Posted: October 12, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Il Soo Ha, Seoul National University Hospital:
Primary Nephrotic syndrome

Additional relevant MeSH terms:
Syndrome
Nephrotic Syndrome
Nephrosis
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action