Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Primary Purpose
Nephrotic Syndrome
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Nephrotic Syndrome focused on measuring Primary Nephrotic syndrome
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tacrolimus
Arm Description
Tacrobell
Outcomes
Primary Outcome Measures
Remission Rate
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
Duration of Remission
Mean duration of remission
Full Information
NCT ID
NCT01162005
First Posted
July 12, 2010
Last Updated
September 5, 2018
Sponsor
Seoul National University Hospital
Collaborators
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01162005
Brief Title
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Official Title
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Chong Kun Dang Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome
Keywords
Primary Nephrotic syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus
Arm Type
Experimental
Arm Description
Tacrobell
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Trcrobell
Intervention Description
dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year
Primary Outcome Measure Information:
Title
Remission Rate
Description
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
Time Frame
12-month treatment period
Secondary Outcome Measure Information:
Title
Duration of Remission
Description
Mean duration of remission
Time Frame
12-month treatment period
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ILSOO Ha, MD, PhD
Organizational Affiliation
Seoul National Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
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