Nephrotic Syndrome
Conditions
Keywords
Primary Nephrotic syndrome
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.
Interventions
DRUGTacrolimus
dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year
Sponsors
Chong Kun Dang Pharmaceutical
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Remission | 12-month treatment period | Mean duration of remission |
Countries
South Korea
Participant flow
Recruitment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 44 |
| SRNS Group SRNS: steroid resistant nephrotic syndrome
Absence of remission after four weeks of steroid therapy. | 33 |
| Total | 77 |
Baseline characteristics
| Characteristic | SDNS/FRNS Group | SRNS Group | Total |
|---|---|---|---|
| Age, Continuous | 11.4 years STANDARD_DEVIATION 4.2 | 7.9 years STANDARD_DEVIATION 4.2 | 9.9 years STANDARD_DEVIATION 4.2 |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Male | 35 Participants | 19 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 33 |
| other Total, other adverse events | 3 / 44 | 16 / 33 |
| serious Total, serious adverse events | 0 / 44 | 4 / 33 |
Outcome results
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
Time frame: 12-month treatment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SDNS/FRNS | Remission Rate | 34 Participants |
| SRNS | Remission Rate | 13 Participants |
p-value: 0.001t-test, 2 sided
Secondary
Duration of Remission
Mean duration of remission
Time frame: 12-month treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SDNS/FRNS | Duration of Remission | 4.6 months | Standard Deviation 2.9 |
| SRNS | Duration of Remission | 4.0 months | Standard Deviation 3.2 |