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| ID | Type | Description | Link |
|---|---|---|---|
| INS-Tacrobell-Pediatrics | Other Identifier | Seoul National University Hospital |
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| Name | Class |
|---|---|
| Chong Kun Dang Pharmaceutical | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus | Experimental | Tacrobell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12-month treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Remission | Mean duration of remission | 12-month treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ILSOO Ha, MD, PhD | Seoul National Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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From July 2010 to August 2013, children with refractory NS were enrolled.
It was conducted at three centers in Korea after obtainment of informed consent.
( Seoul National University Children's Hospital, Samsung Medical Center, Asan Medical Center Children's Hospital)
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| ID | Title | Description |
|---|---|---|
| FG000 | SDNS/FRNS Group | Indicative of two or more relapses during tapering or within 14 days of stopping steroid therapy or more than four relapses within one year or at least two within six months SDNS: steroid-dependent nephrotic syndrome; FRNS: frequent-relapsing nephrotic syndrome; |
| FG001 | SRNS Group | Absence of remission after four weeks of steroid therapy SRNS: steroid-resistant nephrotic syndrome |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SDNS/FRNS Group | SDNS: steroid dependent nephrotic syndrome FRNS: frequent relapsing nephrotic syndrome Indicative of two or more relapses during tapering or within 14 days of stopping steroid therapy or more than four relapses within one year or at least two within six months |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 12-month treatment period |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SDNS/FRNS Group | Indicative of two or more relapses during tapering or within 14 days of stopping steroid therapy or more than four relapses within one year or at least two within six months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased renal function | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient glycosuria | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hee Gyung Kang | Seoul National University Children's Hospital | +82-2-2072-0658 | pedneph@snuh.org |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| SRNS Group |
SRNS: steroid resistant nephrotic syndrome Absence of remission after four weeks of steroid therapy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Duration of Remission | Mean duration of remission | Posted | Mean | Standard Deviation | months | 12-month treatment period |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 3 |
| 44 |
| EG001 | SRNS Group | Absence of remission after four weeks of steroid therapy | 0 | 33 | 4 | 33 | 16 | 33 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Gastrointestinal trouble | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Transient hyperglycemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Itching sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |