CTRI/2019/01/017091
Recruiting
Phase 3
Open label, randomized, controlled trial to compare the efficacy of daily therapy with low dose prednisolone versus standard therapy on alternate days in patients with frequently relapsing/steroid dependent nephrotic syndrome
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Indian Council of Medical Research
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children aged 2\-18 yr with frequently relapsing or steroid dependent nephrotic syndrome
- •Written informed consent from parents
Exclusion Criteria
- •Steroid resistant nephrotic syndrome
- •Congenital nephrotic syndrome
- •Nephrotic syndrome secondary to systemic disease (systemic lupus erythematosus, IgA nephropathy, infection with HIV or hepatitis B or C)
- •Estimated glomerular filtration rate below 60 ml/min/1\.73 sq. m
- •Recent (during the last 6\-months) therapy with long term alternate day prednisolone for \>3\-months, levamisole, cyclophosphamide or mycophenolate mofetil
- •History of therapy with cyclosporine, tacrolimus or rituximab
- •Significant steroid toxicity, as defined by BMI \>2 SDS; stage 2 hypertension; cataract, glaucoma; fasting glucose levels \>100 mg/dl; history of steroid psychosis
Outcomes
Primary Outcomes
Not specified
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