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Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

This study has been completed.
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Il Soo Ha, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01162005
First received: July 12, 2010
Last updated: October 24, 2016
Last verified: October 2016
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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: 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

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 12, 2010
Last Updated: October 24, 2016
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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

ClinicalTrials.gov processed this record on December 05, 2016