Investigation of immunosuppressants therapy associated therapeutic outcomes toxicity outcomes and cost outcomes in paediatric patients with nephrotic syndrome
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
Dr Shashikala Wali
KLE college of pharmacy