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Clinical Trials/CTRI/2025/10/095987
CTRI/2025/10/095987
Not yet recruiting
Not Applicable

Investigation of immunosuppressants therapy associated therapeutic outcomes toxicity outcomes and cost outcomes in paediatric patients with nephrotic syndrome

KLE college of pharmacy1 site in 1 country150 target enrollmentStarted: November 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
KLE college of pharmacy
Enrollment
150
Locations
1
Primary Endpoint
Remission rate and relapse frequency

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
1.00 Year(s) to 18.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Remission rate and relapse frequency

Time Frame: after 15 days

Incidence and severity of drug toxicity

Time Frame: after 15 days

Cost comparison among immunosuppressants

Time Frame: after 15 days

Secondary Outcomes

  • Change in health related quality of life scores(Validation and impact of the patient information leaflet)

Investigators

Sponsor
KLE college of pharmacy
Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Dr Shashikala Wali

KLE college of pharmacy

Study Sites (1)

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