A Multicenter randomized controlled study of short steroid treatment for relapse of nephrotic syndrome.
- Conditions
- Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
- Registration Number
- CTRI/2022/03/041221
- Lead Sponsor
- Pankaj Hari
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients with steroid sensitive nephrotic syndrome with at least one relapse in the preceding 12 months, apart from current relapse
2. Age between 2 and 18 years
3. In relapse when enrolled, presenting within 3 days of starting therapy
4. Parents willing to give informed written consent
1.Current or past history of steroid resistant nephrotic syndrome
2.Three or more relapses in the last 12 months
3. Current relapse on alternate day steroids
4. Therapy with oral or intravenous cyclophosphamide in the preceding 6 months or intravenous rituximab in the preceding 12 months
5. Immunosuppression plan likely to be changed in the next 12 months
6. Presentation with life-threatening infection (e.g., cellulitis, peritonitis, pneumonia) requiring hospital admission
7. Secondary nephrotic syndrome (e.g., lupus erythematosus, IgA nephropathy, amyloidosis)
8. Known chronic infection (tuberculosis, HIV, hepatitis B or C)
9. Known malignancy
10. Estimated glomerular filtration rate <60 ml/min/1.73 m2
11. Residing more than 100 km away or unwilling to come for regular follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with frequent relapses <br/ ><br>Timepoint: 1 Year
- Secondary Outcome Measures
Name Time Method 1. Time to remission <br/ ><br>2. Proportion of treatment failure <br/ ><br>3. Time to first relapse <br/ ><br>4. Frequency of relapses <br/ ><br>5. Cumulative prednisolone requirement (mg/kg) <br/ ><br>6. Therapy associated adverse events, including obesity, cushingoid habitus, cataract, glaucoma and hypertension <br/ ><br>7. Growth velocity <br/ ><br>8. Frequency and type of infectionsTimepoint: 1 Year