A clinical trial comparing daily versus alternate day prednisolone in children with nephrotic syndrome.
Phase 3
Completed
- Conditions
- Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
- Registration Number
- CTRI/2020/04/024596
- Lead Sponsor
- Jawaharlal Nehru Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Children in the age group of 2-14 years diagnosed as SDNS/FRNS, who have at least 6 months follow up record at this centre, shall be considered for enrolment in this trial.
Exclusion Criteria
1. Age at onset of nephrotic syndrome <1year or >10year.
2. Use of alternative treatment other than prednisolone
3. Biopsy showing pathology other than MCNS.
4. Secondary nephrotic syndrome.
5. Late steroid resistance.
6. Residing >100km from the centre or unwilling to follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse frequency.Timepoint: At Enrolment,At 1 year
- Secondary Outcome Measures
Name Time Method 1. safety (side effect of corticosteroids) <br/ ><br>2. Time to first relapse <br/ ><br>3. Proportion of patients relapse-free <br/ ><br>4. Cumulative steroid dose used <br/ ><br>5. Infection episodes <br/ ><br>6. Need for alternative medications.Timepoint: 3 monthly during 1 year followup