| CTRI Number |
CTRI/2025/05/087429 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
New medicine for treatment of nephrotic syndrome in children |
|
Scientific Title of Study
|
Oral methylprednisolone versus prednisolone: A pilot randomised control trial in treatment of first episode nephrotic syndrome in children, non-inferiority trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Chandra |
| Designation |
Junior resident |
| Affiliation |
SCB Medical College and Hospital |
| Address |
SVPPGIP, Pediatric medicine department, pediatric nephrology division, room no 9, Cuttack
Cuttack
ORISSA
753002
India |
| Phone |
08653841216 |
| Fax |
|
| Email |
draishwaryachandra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subal Kumar Pradhan |
| Designation |
Associate professor |
| Affiliation |
SCB Medical college and Hospital |
| Address |
SVPPGIP, Pediatric medicine department, pediatric nephrology division, room no 9, Cuttack
SCB Medical College and Hospital, Pediatrics Department, Manglabagh, Cuttack
Cuttack
ORISSA
753002
India |
| Phone |
09777860915 |
| Fax |
|
| Email |
drsubal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subal Kumar Pradhan |
| Designation |
Associate professor |
| Affiliation |
SCB Medical college and Hospital |
| Address |
SVPPGIP, Pediatric medicine department, pediatric nephrology division, room no 9, Cuttack
SCB Medical College and Hospital, Pediatrics Department, Manglabagh, Cuttack
ORISSA
753002
India |
| Phone |
09777860915 |
| Fax |
|
| Email |
drsubal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| SCB Medical College and Hospital, Manglabagh, Cuttack, Odisha, India. Pin 753007 |
|
|
Primary Sponsor
|
| Name |
SCB Medical College and Hospital |
| Address |
SCB Medical College and Hospital, Pediatrics Dept, Manglabagh, Cuttack, Odisha, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subal Pradhan |
SVPPGIP |
SVPPGIP, Pediatric medicine department, pediatric nephrology division, room no 9, Cuttack
Cuttack
ORISSA |
09777860915
drsubal@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SCB Medical college and hsopital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N049||Nephrotic syndrome with unspecified morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
methylprednisolone |
GROUP A will receive dose of methylprednisolone 1.6 mg/kg/day after food daily for 4 weeks (single doses/
OD) followed by 1.2 mg/kg/alternate day single dose after food for 4 weeks |
| Comparator Agent |
prednisolone |
GROUP B will receive dose of prednisolone 2.0 mg/kg/day daily after food for 4 weeks (single doses/OD)) .
Then 1.5 mg/kg/alternate day single dose after food for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
children between the ages of 4 and 14 years old with primary diagnosis of nephrotic syndrome first attack |
|
| ExclusionCriteria |
| Details |
children less than 4 years or more than 14 years, children having hypertension, hematuria, raised creatinine level or with secondary nephrotic syndrome due to any systemic disorder or drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative study of time taken to achieve remission from first episode of Nephrotic syndrome Between two drugs |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of relapses during one year follow up |
one year |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsubal@rediffmail.com].
- For how long will this data be available start date provided 17-12-2025 and end date provided 17-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Nephrotic syndrome is the commonest glomerular disease in children. Corticosteroids are
the first line treatment. Almost 80% shows steroid responsiveness and achieve complete
remission in 4 weeks. Oral prednisolone for 8-12 weeks (as per KDIGO 2021 GUIDELINES)
are used. Methyl prednisolone being a corticosteroid, with 1.25 times glucocorticoid
effect and 0.625 times mineralocorticoid effect compared to prednisolone when
given in equivalent dose can show low Na+ retention and there will be less chances of
developing hypertension. Considering lesser sodium retaining activity, methyl prednisolone might have lesser side
effects as compared to prednisolone. The aim of this study is to compare the effectiveness
and safety of methylprednisolone in children with first episode of idiopathic nephrotic
syndrome in a prospective randomized controlled trial. Although studies on IV methylprednisolone have been done for treatment of primary
nephrotic syndrome but study on oral methylprednisolone is limited. |