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CTRI Number  CTRI/2021/11/037940 [Registered on: 11/11/2021] Trial Registered Prospectively
Last Modified On: 20/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of single dose steroid versus divided dose steroid in patients with nephrotic syndrome  
Scientific Title of Study   A prospective randomized control trial to compare the safety and efficacy of single dose prednisolone versus divided dose prednisolone in first episode of nephrotic syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tania khan 
Designation  Junior Resident 
Affiliation  Institute of child Health,kolkata 
Address  Institute of child health Nephrology department opd no 122
11 Dr Biresh Guha Street, Kolkata 700017 Institute of child health Nephrology department opd no 122 west bengal India
Kolkata
WEST BENGAL
7000017
India 
Phone  7278685725  
Fax    
Email  taniacnmc92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajiv Sinha 
Designation  Professor 
Affiliation  Institute of child Health,kolkata 
Address  11 Dr Biresh Guha Street, Park circus 700017
11 Dr Biresh Guha Street, Kolkata 700017 west bengal India
Kolkata
WEST BENGAL
700017
India 
Phone  9330819380  
Fax    
Email  rajivsinha_in@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Tania khan 
Designation  Junior Resident 
Affiliation  Institute of child Health,kolkata 
Address  11 Dr Biresh Guha Street, Institute of child Health NEPHROLOGY WARD,OPD 122 Kolkata 700017 west bengal India
11 Dr Biresh Guha Street, Kolkata 700017 west bengal India
Kolkata
WEST BENGAL
700017
India 
Phone  7278685725  
Fax    
Email  taniacnmc92@gmail.com  
 
Source of Monetary or Material Support  
Institutional(Institute of child Health ,kolkata) 
 
Primary Sponsor  
Name  Institute of child health kolkata 
Address  11 biresh guha street kolkata 700017 West bengal,India. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tania Khan  Institute of child health kolkata,  Department of Nephrology,nephrology ward, 11 Dr Biresh Guha Street Kolkata 700017
Kolkata
WEST BENGAL 		 7278685725

taniacnmc92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee[Institute of child Health kolkata]  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N04||Nephrotic syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Divided dose of prednisolone  children with first episode nephrotic syndrome in the comparator arm will be given prednisolone @2mg/kg/day in two divided doses daily for 6 weeks 
Intervention  single dose prednisolone  children with first episode nephrotic syndrome in the intervention arm will be given prednisolone @2mg/kg/day as a single morning dose daily for 6 weeks  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All children between 1 to 12 years , with first episode steroid naïve nephrotic syndrome and being commenced on prednisolone were included in this study. 
 
ExclusionCriteria 
Details  1.Children with previous history of nephrotic syndrome
2.Children already on steroids.
3.Children with allergy to egg or egg components .
4.Children below 1yr and above 12yrs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of effect of single dose versus divided dose prednisolone on HPA axis at 6 weeks of treatment in children with first episode of nephrotic syndrome.  6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Documentation of the time to remission [Remission: urine albumin nil or trace (or proteinuria 4 mg/m2/h) for 3 consecutive early morning specimens]
2. Documentation of number of relapses and the time to first relapse (if any) in the two study groups till 6 months after completion of steroid therapy.
 		 6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/12/2021 
Date of Study Completion (India) 20/01/2023 
Date of First Enrollment (Global)  08/12/2021 
Date of Study Completion (Global) 20/01/2023 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [taniacnmc92@gmail.com].

  6. For how long will this data be available start date provided 01-06-2023 and end date provided 30-06-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized parallel group active control trial comparing the safety and efficacy of prednisolone[2mg/kg/day]in daily single dose versus divided dose for 6 months in 60 patients with first episode of nephrotic syndrome that will be conducted in Institute Of Child Health,kolkata.The primary outcome measured will be comparison of effect of single dose versus divided dose prednisolone on HPA axis at the completion of 6 week daily treatment . The secondary outcomes will be documentation of time to remission and documentation of number of relapses and the time to first relapse(if any)in the two study groups till 6 months after completion of steroid therapy. 
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