Home » Trials » SLCTR/2016/027
A randomized control trial on the efficacy of two different prolonged corticosteroid regimes in children with steroid sensitive nephrotic syndrome
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SLCTR Registration Number
SLCTR/2016/027
Date of Registration
The date of last modification
Apr 30, 2019
Scientific Title of Trial
A randomized control trial on the efficacy of two different prolonged corticosteroid regimes in children with steroid sensitive nephrotic syndrome
Public Title of Trial
A comparative study on steroid therapy in children with nephrotic syndrome
Disease or Health Condition(s) Studied
Nephrotic syndrome
Scientific Acronym
None
Public Acronym
None
Brief title
A comparative study on Steroid therapy in nephrotic syndrome.
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
3.2, 11.8.2015 (ERC: Ruhuna)
What is the research question being addressed?
How does the different dosing and duration of steroid therapy affect the duration of remission, relapse rate, and the time taken for the development of frequently relapsing nephrotic syndrome or steroid dependency
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Number of Arms - 4
a. Patients with 1st episode of nephrotic syndrome will be allocated into 2 treatment arms
i. Experimental group – 7 month treatment arm. (Jayantha2002a)
ii. Control group – 6 month treatment arm (KDIGO regime)
b. Patients presenting with relapsing nephrotic syndrome will be allocated into 2 treatment arms.
i. Experimental group – relapse regime of the 7 month treatment arm (Jayantha2002b)
ii. Control group – Relapse regime of the 6month treatment arm (KDIGO relapse regime)
Method of randomization and the allocation of patients
Table of random numbers will be used. A randomization list will be generated by using the digits 0-9, 1 per treatment assignment starting with the top row and working downwards. 7 months treatment arm assigned for digits 0-4 and the KDIGO treatment arm assigned to digits 5-9. Randomization of patients with 1st episode and patients presenting with relapsing nephrotic syndrome will be done separately.
Details of the intervention in each arm
a. First episode
i. 7 Months treatment arm(Jayantha 2002a)
Prednisolone: 60mg/m2/day for 28 days; 60mg/m2/eod for 28 days; 50 mg/m2/eod for 28 days; 40mg/m2/eod for 28 days; 30mg/m2/eod for 28 days; 20mg/m2/eod for 28days; 10 mg/m2 eod for 28 days
Relapses will be treated with Prednisolone 60mg/m2 daily until urine is protein free for 3 days; then 60mg/m2/eod for 28 days; 50 mg/m2/eod for 28 days; 40mg/m2/eod for 28 days; 30mg/m2/eod for 28 days; 20mg/m2/eod for 28days;10 mg/m2 eod for 28 days
ii. 6 month treatment arm(KDIGO)
Prednisolone: 60mg/m2/day for 42 days; 40mg/m2/eod for 42 days; 30mg/m2/eod for 28 days; 22.5mg/m2/eod for 28 days; 15mg/m2/eod 28 days
Relapses will be treated with Prednisolone 60mg/m2 daily until urine is protein free for 3 days; then 40mg/m2/eod for 28 days
b. Patients presenting with relapsing nephrotic syndrome
i. 7 Months relapsing treatment arm(Jayantha 2002b) Prednisolone: 60mg/m2 daily until urine is protein free for 3 days; then 60mg/m2/every other day for 28 days; 50 mg/m2/eod for 28 days; 40mg/m2/eod for 28 days; 30mg/m2/eod for 28 days; 20mg/m2/eod for 28days; 10mg/m2/eod for 28 days
ii. 6 month relapse treatment arm(KDIGO)
Prednisolone: 60mg/m2 daily until urine is protein free for 3 days; then 40mg/m2/eod for 28 days
Inclusion criteria
Patients presenting with nephrotic syndrome between 1 yr to 12 yrs of age.
1st episode of nephrotic syndrome, defined as patients with gross proteinuria (+++ or more) with UPcr > 200mg/mmol hypoalbuminemia (albumin>2.5g/dl) and odema.
Relapse of nephrotic syndrome, defined as gross proteinuria of +++ or more or UPcr >200mg/mmol for more than 3 days in a child who has been previously diagnosed of having nephrotic syndrome.
Exclusion criteria
Primary outcome(s)
|
1.
|
[ Monthly until remission is reached, and then every 2 months for a period of three years ] |
Secondary outcome(s)
|
1.
Stunting Obesity Cataract |
[ Height and weight will be measured every month while on treatment and every 3months while in remission and plotted in the centile charts ] |
Target number/sample size
64
Countries of recruitment
Sri Lanka
Anticipated start date
2016-11-02
Anticipated end date
2019-10-30
Date of first enrollment
2016-11-08
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2015-09-15
Approval number
3.2, 11.8.2015 (ERC: Ruhuna)
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Professor U.K. Jayantha
Chair and Professor of Paediatrics
Department of Paediatrics.
Faculty of Medicine,
University of Ruhuna,
Galle, Sri Lanka
Tel: 0777920414
Mob: 0777920414
u_k_jayantha@yahoo.com
Contact Person for Public Queries
Dr. U.K.S.R. Udupitiya
Co- researcher.
University Renal Clinic, Teaching Hospital, Karapitiya
Tel: 0776011665
Mob: 0776011665
u.k.s.r.udupitiya@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
