A study to compare efficacy of daily prednisolone versus standard alternate day prednisolone in patients with frequently relapsing nephrotic syndrome.

Phase 4

• Conditions: Health Condition 1: null- Nephrotic syndrome

• Registration Number: CTRI/2012/12/003194
• Lead Sponsor: Council of Scientific and Industrial Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Children aged 2-16 years with frequently relapsing/steroid dependent nephrotic syndrome.

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.

Intake of immunosuppressive medications other than oral prednisolone in the preceding 6 months

One or more features of steroid toxicity, as defined by body mass index >95th percentile for age and gender, presence of cataract or stage 2 hypertension.

Refusal of informed parental consent

High steroid threshold to prevent relapses ( >1 mg/kg on alternate days)

Recent ( <6 months) relapse associated with need of hospital admission e.g. for severe life threatening infection

Occurrence of more than two relapses during any 6-months, or 3 or more relapses in 12 months while receiving intervention, will be taken as trial deviate and require initiation of alternative therapy.

Occurrence of late resistance to corticosteroids

Subjects in whom the intervention cannot be given for one year, or is interrupted for more than two weeks period of time; e.g. subjects who become very sick and have to be withdrawn from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare, over 12 months, the frequency of relapses in patients with frequently relapsing nephrotic syndrome administered therapy with prednisolone daily in low doses versus its adminsitered on alternate days (standard therapy). <br/ ><br>Timepoint: To compare, at 12 months, the frequency of relapses in patients with frequently relapsing nephrotic syndrome administered therapy with prednisolone daily in low doses versus its adminsitered on alternate days (standard therapy). <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Time to first relapse <br/ ><br>Proportion of patients with sustained remission or frequent relapses. <br/ ><br>Frequency and types of infections. <br/ ><br>Proportion of patients showing suppression of the hypothalmic- pituitary-adrenal axis, as determined by the ACTH stimulation test(Synacthen test), at the onset of study and 12 months follow up. <br/ ><br>Proportion of patients with corticosteroid related adverse events.Timepoint: 1years