Trial Outcomes & Findings for Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children (NCT NCT01162005)
NCT ID: NCT01162005
Last Updated: 2019-02-07
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
12-month treatment period
Results posted on
2019-02-07
Participant Flow
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)
Participant milestones
| Measure |
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;
|
SRNS Group
Absence of remission after four weeks of steroid therapy SRNS: steroid-resistant nephrotic syndrome
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
33
|
|
Overall Study
COMPLETED
|
44
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Baseline characteristics by cohort
| Measure |
SDNS/FRNS Group
n=44 Participants
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
|
SRNS Group
n=33 Participants
SRNS: steroid resistant nephrotic syndrome
Absence of remission after four weeks of steroid therapy.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
7.9 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
9.9 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-month treatment periodComplete 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
Outcome measures
| Measure |
SDNS/FRNS
n=44 Participants
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
|
SRNS
n=33 Participants
Absence of remission after four weeks of steroid therapy
|
|---|---|---|
|
Remission Rate
|
34 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12-month treatment periodMean duration of remission
Outcome measures
| Measure |
SDNS/FRNS
n=44 Participants
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
|
SRNS
n=33 Participants
Absence of remission after four weeks of steroid therapy
|
|---|---|---|
|
Duration of Remission
|
4.6 months
Standard Deviation 2.9
|
4.0 months
Standard Deviation 3.2
|
Adverse Events
SDNS/FRNS Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SRNS Group
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SDNS/FRNS Group
n=44 participants at risk
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
|
SRNS Group
n=33 participants at risk
Absence of remission after four weeks of steroid therapy
|
|---|---|---|
|
Renal and urinary disorders
Decreased renal function
|
0.00%
0/44 • 12 months
|
12.1%
4/33 • Number of events 4 • 12 months
|
Other adverse events
| Measure |
SDNS/FRNS Group
n=44 participants at risk
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
|
SRNS Group
n=33 participants at risk
Absence of remission after four weeks of steroid therapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Transient glycosuria
|
6.8%
3/44 • Number of events 3 • 12 months
|
24.2%
8/33 • Number of events 8 • 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/44 • 12 months
|
6.1%
2/33 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal trouble
|
0.00%
0/44 • 12 months
|
3.0%
1/33 • Number of events 1 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/44 • 12 months
|
3.0%
1/33 • Number of events 1 • 12 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/44 • 12 months
|
6.1%
2/33 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Transient hyperglycemia
|
0.00%
0/44 • 12 months
|
3.0%
1/33 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Itching sensation
|
0.00%
0/44 • 12 months
|
3.0%
1/33 • Number of events 1 • 12 months
|
Additional Information
Hee Gyung Kang
Seoul National University Children's Hospital
Phone: +82-2-2072-0658
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place