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临床试验/CTRI/2025/10/095987
CTRI/2025/10/095987尚未招募不适用

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

KLE college of pharmacy1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Remission rate and relapse frequency

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Remission rate and relapse frequency

时间窗: after 15 days

Incidence and severity of drug toxicity

时间窗: after 15 days

Cost comparison among immunosuppressants

时间窗: after 15 days

次要结局

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

研究者

发起方
KLE college of pharmacy
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Shashikala Wali

KLE college of pharmacy

研究点 (1)

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