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Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

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ClinicalTrials.gov Identifier: NCT01162005
Recruitment Status : Completed
First Posted : July 14, 2010
Results First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Il Soo Ha, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: Tacrolimus Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Study Start Date : July 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Remission Rate [ Time Frame: 12-month treatment period ]
    Complete remission at 12 months Per KDIGO clinical practice guideline for glomerulonephritis (2012): Complete remission (CR), urine protein creatinine ratio below 200mg/g (20mg/mmol) or 1+ of protein on urine dipstick for 3 consecutative days


Secondary Outcome Measures :
  1. Duration of Remission [ Time Frame: 12-month treatment period ]
    Mean duration of remission



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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 glomerular filtration rate < 60 mL/min/1.73m2
  • with active hepatitis

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
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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
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Study Chair: ILSOO Ha, MD, PhD Seoul National Children's Hospital

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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 Posted: July 14, 2010    Key Record Dates
Results First Posted: February 7, 2019
Last Update Posted: February 7, 2019
Last Verified: September 2018
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:
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Nephrotic Syndrome
Nephrosis
Syndrome
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