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CTRI Number  CTRI/2025/10/095987 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Diagnostic
Process of Care Changes 
Study Design  Other 
Public Title of Study   Studying on how medicines affect children with kidney problems benefits side effects and costs 
Scientific Title of Study   Investigation of immunosuppressants therapy associated therapeutic outcomes toxicity outcomes and cost outcomes in paediatric patients with nephrotic syndrome 
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 Shashikala Wali 
Designation  Associate Professor 
Affiliation  KLE college of pharmacy 
Address  Department of Pharmacy Practice Room no 15 KLE College of Pharmacy Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9902944602  
Fax    
Email  shashikalawali@klepharm.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashikala Wali 
Designation  Associate Professor 
Affiliation  KLE college of pharmacy 
Address  Department of Pharmacy Practice Room no 15 KLE College of Pharmacy Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9902944602  
Fax    
Email  shashikalawali@klepharm.edu  
 
Details of Contact Person
Public Query  
Name  Anjalna Shaikh 
Designation  Intern 
Affiliation  KLE college of Pharmacy 
Address  Department of Pharmacy Practice Room no 15 KLE college of Pharmacy Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  8217692049  
Fax    
Email  shaikhanjalna3@gmail.com  
 
Source of Monetary or Material Support  
KLEs Dr Prabhakar Kore Hospital and Medical Research Centre Nehru nagar Belagavi 590010 Karnataka India  
 
Primary Sponsor  
Name  KLE college of pharmacy 
Address  Nehru Nagar Belagavi 590010 Karnataka 
Type of Sponsor  Research institution 
 
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 Shashikala Wali  KLEs Dr Prabhakar Kore Hospital and Medical Research Centre   Department of Pediatric Nehphrology Nehru Nagar Belagavi Belagavi
Belgaum
KARNATAKA 		 9902944602

shashikalawali@klepharm.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLECOPBGM ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Immunosuppressants   The study compares the effectiveness, safety, and cost of different immunosuppressants against each other to determine which is best for these children. For many patients, steroid therapy (such as prednisolone) is typically the first treatment and acts as the comparator, especially for those who fail or relapse on steroids 
Intervention  Immunosuppressants  These medications are given to children aged 1-18 years who do not respond to or cannot tolerate steroid therapy. The research will monitor how well these drugs work for remission, the frequency and seriousness of side effects, and their impact on quality of life. The study will record costs-both direct (medicine, tests, visits) and indirect (missed school or work)-and provide structured educational materials to families to explain the medicines and disease in simple terms 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Paediatric patients aged 1 to 18 years. Diagnosed with steroid resistant or steroid dependent nephrotic syndrome
Patients who are currently receiving or planned to receive immunosuppressant
Patients and guardians who provide written informed consent 
 
ExclusionCriteria 
Details  Patient with secondary causes of nephrotic syndrome like lupus nephritis or infections or malignancy
Known chronic liver disease or heart failure or any other severe systemic illness
Parents guardians unwilling or unable to provide written informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Remission rate and relapse frequency
Incidence and severity of drug toxicity
Cost comparison among immunosuppressants 		 after 15 days  
 
Secondary Outcome  
Outcome  TimePoints 
Change in health related quality of life scores
Validation and impact of the patient information leaflet 		 after 15 days 
 
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)   01/11/2025 
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="0"
Months="6"
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 - NO
Brief Summary   This research project aims to study children with nephrotic syndrome a kidney condition that causes high protein loss in urine who need special medicines called immunosuppressants because ordinary steroid treatments either don’t work or cause frequent problems
Study Purpose
The project wants to find out how well different immunosuppressant medications work, what side effects they cause, and how much families spend on these treatments 
What Is Being Done
Children aged 1 to 8 with steroid resistant or steroid dependent nephrotic syndrome are included 
Doctors will track how the medicines help (or don’t help), check for bad reactions, and see how the illness and treatment affect children’s daily lives-like going to school and playing
The researchers also made an easy-to-read information leaflet for families. It explains the medicines and disease simply, hoping that kids and parents will better understand and manage health
Why Does It Matter
These treatments can lead to serious side effects, and high costs can make life harder for families, sometimes causing financial stress 
By collecting and analyzing treatment results, side effects, and costs, the team hopes to recommend safer, more effective therapies and help families with better information about their children’s condition and care .
This work should help improve medical care for children with difficult kidney disease, make treatment more affordable, and support both patients and their families.
 
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