Efficacy of a shorter duration of prednisolone treatment for children in relapse with steroid sensitive nephrotic syndrome: A randomised controlled study
- Conditions
- Health Condition 1: null- Steroid Sensitive Nephrotic Syndrome
- Registration Number
- CTRI/2015/11/006345
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 114
1. Patients diagnosed with steroid sensitive nephrotic syndrome
2. Currently in relapse
3. Those who give written informed consent
1. Patients diagnosed with steroid resistant Nephrotic Syndrome
2. Patients with frequent relapses (defined as 2 or more relapses in 6 months or >3 in 12 months) or steroid dependence (defined as 2 consecutive relapses on alternate day therapy or within 2 weeks of discontinuation of therapy)
3. Known secondary cause (e.g. Hepatitis B, SLE, HSP)
4. Patients on alternate regimens with levamisole/cyclophospahmide/mycophenolate mofetil/azathioprine/rituximab
5. Patients who have not recieved atleast 4 weeks of daily steroids at 2 mg/kg followed by 4 weeks of 1.5 mg/kg alternate day steroids during initial episode
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children becoming frequently relapsing nephrotic syndromeTimepoint: 0 and 12 months
- Secondary Outcome Measures
Name Time Method 1. Time to first relpase <br/ ><br>2. Relapse rates <br/ ><br>3. Cumulative dose of steroids <br/ ><br>4. Adverse effects of steroidsTimepoint: 0, 1 mo, 3 mo, 6 mo, 9 mo, 12 mo