Home » Trials » SLCTR/2019/025
Single vs split dose of prednisolone in the treatment relapses of childhood Nephrotic syndrome
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SLCTR Registration Number
SLCTR/2019/025
Date of Registration
The date of last modification
Dec 30, 2024
Scientific Title of Trial
Single vs split dose of prednisolone in the treatment relapses of childhood Nephrotic syndrome
Public Title of Trial
Single vs split dose of prednisolone in the treatment relapses of childhood nephrotic syndrome: A Randomized Controlled Trial
Disease or Health Condition(s) Studied
Nephrotic syndrome
Scientific Acronym
None
Public Acronym
None
Brief title
Single vs split dose of prednisolone in the treatment of childhood nephrotic syndrome relapses
Universal Trial Number
U1111-1230-9350
Any other number(s) assigned to the trial and issuing authority
2018/EC/26: ERC Peradeniya
What is the research question being addressed?
Is a split dose more effective than a single morning dose of prednisolone to achieve early remission in relapses of childhood nephrotic syndrome?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Investigators, Data analysts, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting The paediatric nephrology section of the Professorial Paediatric Unit at Teaching Hospital Peradeniya
Method of randomization Block randomization. Study group and control. Each arm of the study will contain 4 blocks that are randomly selected utilizing random number generator software. (1-4,4-7,7-10,10-14) according to the age and the sample size will be 60 per group
Intervention Patients randomized to Group A will be given oral prednisolne at 60mg/m2 (dose rounded off to the nearest 5mg) as a single morning dose, while Group B will be given the same total dose as two divided doses, of which 2/3 will be given in the morning and the rest in the evening (all doses rounded up to the nearest 5mg). This will be continued until remission is achieved (nil or trace proteinuria for 3 consecutive days) following which all patients will be switched to alternate day prednisolne at 60mg/m2 which will be given as a single morning dose. Crushing of tablet may be done by a nursing officer when required for some paediatric patients.
Inclusion criteria
• Male and female • Between 1 and 14 years of age • With idiopathic nephrotic syndrome • Admitted to the unit with a relapse
Exclusion criteria
Patients with steroid resistant nephrotic syndrome
Patients with secondary nephrotic syndrome
Patients who have been started on treatment for the 1st episode/relapse prior to the admission to our unit
Patients with deranged renal functions
Patients with other associated co morbidities
Presented with first episode of nephrotic syndrome
Primary outcome(s)
|
1.
Remission is defined as a urine test with nil or trace proteinuria for 3 consecutive days. Urine albumin test will be checked every day only from early morning urine sample for assessment of remission Number of days until a remission will be used to compare the test group and the control group |
[ Daily urine analysis and date of remission (for number of days for remission after introducing the intervention) ] |
Secondary outcome(s)
|
1.
Proportion of patients on second line medicine/s who achieved remissions in < 5 days Proportion of patients not on second line medicine/s who achieved remissions in < 5 days |
[ At study completion ] |
Target number/sample size
120 (60 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-08-14
Anticipated end date
2020-02-14
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2019-05-08
Approval number
2018/EC/26
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Faculty of Medicine, University of Peradeniya, Peradeniya |
| Telephone: | +94812388301 |
| Email: | pro@pdn.ac.lk / pro.uop@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Lasanthi Weerasooriya
Senior Registrar in Paediatric Nephrology
Teaching hospital, Peradeniya
0772666474
0812388371
weerasooriya.lk@gmail.com
Contact Person for Public Queries
Dr. Shenal Thalgahagoda
Consultant Paediatric Nephrologist and Senior Lecturer in Paediatrics
Teaching Hospital, Peradeniya and
Faculty of Medicine,
University of Peradeniya,
Sri Lanka
0777804686
0812388371
shenalthalgahagoda@yahoo.co.uk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
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
