FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078098 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Delaying initiation of steroid therapy in steroid sensitive nephrotic syndrome children with relapse to reduce steroid therapy usage 
Scientific Title of Study   Defining relapse with asymptomatic seven-day nephrotic range proteinuria in steroid sensitive nephrotic syndrome to reduce steroid therapy usage: a prospective interventional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Paraselli Saiteja 
Designation  Senior resident 
Affiliation  AIIMS, New Delhi 
Address  DM Pediatric nephrology, Department of Pediatrics, Mother and child building, AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  7358521328  
Fax    
Email  saiteja255835@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pankaj Hari 
Designation  Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Room No 806, Division of Pediatric Nephrology, Department of Pediatrics, Mother and child building, AIIMS, New Delhi.

South West
DELHI
110029
India 
Phone  9560701175  
Fax    
Email  drpankaj.hari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Paraselli Saiteja 
Designation  Senior resident 
Affiliation  AIIMS, NEW DELHI 
Address  DM Pediatric Nephrology Department of Pediatrics Mother and child building AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  7358521328  
Fax    
Email  saiteja255835@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  Ansari Nagar, South west Delhi, 110029, 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 Paraselli Saiteja   AIIMS Pediatric nephrology unit  Pediatric emergency, Pediatric OPD- 2nd floor RAK building, Pediatric ward- 4c, MCB building, Department of pediatrics, Ansari nagar, South west Delhi, 110029, India
South West
DELHI 
7358521328

saiteja255835@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Delaying steroid therapy in relapse of nephrotic syndrome  While the relapse in nephrotic syndrome is defined by 3 consecutive days of nephrotic range proteinuria, there is a dearth of evidence to support the same. Some observational studies have reported spontaneous remission in 14-30% of relapses between 4 to 14 days of onset of nephrotic range proteinuria. Treating these children as relapse will over-diagnose frequent relapsing nephrotic syndrome causing unnecessary steroid toxicity and usage of alternate immunosuppressive therapy. This study is being conducted to see the proportion of children in whom steroid usage can be prevented by delaying the therapy till seven days of asymptomatic nephrotic range proteinuria Child will be started on relapse therapy of 2mg/kg/day of oral prednisolone till remission followed by 1.5mg/kg/day alternate day oral prednisolone for 4 weeks in case of relapse therapy 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Steroid sensitive nephrotic syndrome children aged 3 to 18 years with disease duration of more than 1 year and 3 consecutive days of nephrotic range proteinuria  
 
ExclusionCriteria 
Details  Non adherence to urine protein diary maintenance,
Development of edema within 3 days of onset of nephrotic range proteinuria,
Severe infections mandating stress dose steroids,
Steroid resistant nephrotic syndrome course in the past,
Refusal of consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In children with steroid sensitive nephrotic syndrome (SSNS) aged 3-18 years with 3 days of nephrotic range proteinuria, to estimate the proportion of children in whom steroid therapy is avoided by delaying the diagnosis of relapse till day 7 of asymptomatic nephrotic range proteinuria.  day 7 
 
Secondary Outcome  
Outcome  TimePoints 
To study the time to remission  6 weeks 
To compare the proportion of children in whom steroid therapy is avoided between infrequent relapsing nephrotic syndrome and frequent relapsing nephrotic syndrome/ steroid dependent nephrotic syndrome  6 weeks 
To compare the proportion of children in whom steroid therapy is avoided between proteinuria associated with infections and without infections  6 weeks 
To estimate the proportion of children in need for relapse therapy within 6 weeks of onset of proteinuria  6 weeks 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   01/01/2025 
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  

Incidence of nephrotic syndrome in children varies between 1.2 to 16.9 per lakh, with higher incidence in Asian children. It is characterized by heavy proteinuria, hypoalbuminemia and edema. Majority of the children (85-90%) respond to steroid therapy with complete resolution of proteinuria which is termed as steroid sensitive nephrotic syndrome (SSNS). Though the outcome of SSNS in satisfactory, 50% children have a frequent relapsing or steroid dependent course and 3-10% show late steroid resistance.

Relapse in nephrotic syndrome is defined as three consecutive days of nephrotic range proteinuria. This definition is empirical and not backed by any evidence from previous studies. Frequent relapsing nephrotic syndrome (FRNS) and steroid dependent nephrotic syndrome (SDNS) are at higher risk of steroid toxicity. In order to reduce the steroid toxicity, these children would require alternate immunosuppressive drugs like levamisole, mycophenolate mofetil (MMF), oral cyclophosphamide. These drugs are associated with serious adverse drug reactions like vasculitis, gastrointestinal disturbances, transaminitis, leukopenia etc.

Previous observational studies have reported spontaneous resolution of  proteinuria in 33-50% between 5-10 days of onset of  nephrotic range proteinuria. These studies suggest further waiting against the conventional definition of 3 consecutive days of nephrotic range proteinuria for relapse. Thus, a possible over diagnosis of FRNS/ SDNS and an unnecessary exposure to higher steroid dose and other  immunosuppressive agents can be avoided.

Since the natural history of isolated proteinuria without symptoms in nephrotic syndrome is largely unknown, there is a need for prospective controlled studies for a more accurate definition of relapse in nephrotic syndrome. Hence, this study is being conducted to see if  delaying the diagnosis of relapse till seven-days of asymptomatic nephrotic range proteinuria will reduce the need for steroid usage in SSNS children with 3 days of nephrotic range proteinuria.

 
Close