| CTRI Number |
CTRI/2025/03/083231 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study effectiveness of low dose steroid in nephrotic syndrome. |
|
Scientific Title of Study
|
Efficacy of low dose prednisolone in children with steroid sensitive nephrotic syndrome - An open labelled randomized pilot 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 |
Dr Onkar Singh |
| Designation |
Junior resident |
| Affiliation |
AIIMS BATHINDA |
| Address |
PEDIATRIC DEPARTMENT, AIIMS BATHINDA, PUNJAB
PEDIATRIC DEPARTMENT, AIIMS BATHINDA, PUNJAB
Bathinda
PUNJAB
151005
India |
| Phone |
8387874139 |
| Fax |
|
| Email |
singhonkar275@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raksha Ranjan |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Bathinda |
| Address |
PEDIATRIC DEPARTMENT, AIIMS BATHINDA, PUNJAB
PEDIATRIC DEPARTMENT, AIIMS BATHINDA, PUNJAB
Bathinda
PUNJAB
151005
India |
| Phone |
9952737293 |
| Fax |
|
| Email |
raksharanjan19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raksha Ranjan |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Bathinda |
| Address |
PEDIATRIC DEPARTMENT, AIIMS BATHINDA, PUNJAB
PEDIATRIC DEPARTMENT, AIIMS BATHINDA, PUNJAB
Bathinda
PUNJAB
151005
India |
| Phone |
9952737293 |
| Fax |
|
| Email |
raksharanjan19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims Bathinda, Punjab India
Pincode- 151001 |
|
|
Primary Sponsor
|
| Name |
Aiims Bathinda |
| Address |
Aiims Bathinda, Bathinda Punjab India
pincode - 151001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aiims Bathinda |
Aiims Bathinda |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ONKAR SINGH |
AIIMS BATHINDA |
Room no. 421, Paediatrics department, AIIMS BATHINDA, BATHINDA PUNJAB
Bathinda
PUNJAB |
8387874139
singhonkar275@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee AIIMS Bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low dose steroid |
Patient in intervention group will receive low dose (1.5 mg/kg/day) prednisolone till remission followed by 1.5mg/kg alternate day for two weeks and 1mg/kg alternate day for next 2 weeks |
| Comparator Agent |
Standard dose steroid |
Patient in control group will be started on standard regimen (2mg/kg/day) prednisolone till remission followed by 1.5mg/kg alternate day for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1)Children aged between 2 to 13 years present to pediatric OPD or IPD with steroid sensitive nephrotic syndrome.
2)Those in relapse
3)Those patients who were not receiving prednisone at the time of relapse and had never before received other steroid sparing drugs.
|
|
| ExclusionCriteria |
| Details |
1)Steroid resistant and steroid dependent
2)Patient with nephrotic syndrome due to secondary causes.
3)Patients with frequent relapses
4)Patients in whom initial episode was not treated with at least 2 mg/kg of daily steroids for 4 weeks followed by 4 weeks of 1.5 mg/kg alternate day steroids during.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of relapses in steroid sensitive nephrotic syndrome on low dose prednisolone |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Comparison of steroid toxicity in both the groups.
2)Difference in Linear growth with both the regimen
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This open-label randomized controlled trial will be conducted over 18 months aiming to evaluate the effectiveness to reduced doses of prednisolone during relapses in steroid sensitive nephrotic syndrome (SSNS) in children aged 2-13 years. The intervention group will receive low dose prednisolone 1.5mg/kg/day until remission, followed bt 1.5mg/kg alternate day for 2 weeks and 1mg/kg alternate day for next 2 weeks and the control group will receive the standard regimen 2mg/kg/day until remission,followed by 1.5 mg /kg alternate day for 4 weeks. The primary outcome is the rate of relapses in SSNS.
|