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A study to assess the response to two different doses of prednisolone in children with relapse of nephrotic syndrome.

A comparison of two doses of prednisolone for relapses in children with steroid sensitive nephrotic syndrome: a randomized controlled non inferiority trial. - PRONS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014075
Enrollment
60
Registered
2018-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Nephrotic Syndrome

Interventions

Intervention1: Oral Prednisolone: 1mg/kg/day till remission or two weeks whichever is earlier Control Intervention1: Oral Prednisolone: (Active control) 2mg/kg/day till remission or 2 weeks whichever

Sponsors

Chacha Nehru Bal Chikitsalaya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1-12 years of age with idiopathic steroid sensitive nephrotic syndrome presenting with relapse will be eligible for the study.

Exclusion criteria

Exclusion criteria: Children receiving or within 3â??months after receiving immunosuppressive medications like levamisole, cyclophosphamide, cyclosporine or rituximab Children with concurrent infections Children having associated co-morbidities.

Design outcomes

Primary

MeasureTime frame
The difference in the mean time to achieve remission between the group of children receiving 1mg/kg/day prednisolone and the group receiving 2mg/kg/day prednisolone during a relapse in children with steroid sensitive nephrotic syndrome.Timepoint: Up to maximum 2 weeks after randomization—

Secondary

MeasureTime frame
proportion of children with relapse of nephrotic syndrome, who achieved remission with 1mg/kg/day versus 2mg/kg/day of oral prednisolone.Timepoint: up to maximum of 4 weeks after randomization;The cumulative dose of steroids and adverse effects of glucocorticoids (hypertension, BMI, Serum calcium levels) between children in the treatment arms.Timepoint: In subsequent 12 months post randomization;The number of relapses over the subsequent 12 months following randomization into the treatment arms. Timepoint: over subsequent 12 months post randomization;To compare the time to first relapse following remission achieved after treatment of a relapse with 1mg/kg/day versus 2mg/kg/day of oral prednisolone.Timepoint: In due course over 12 months post randomization—

Countries

India

Contacts

Public ContactSeenam Sheikh Hanafi

Chacha Nehru Bal Chikitsalaya, an autonomous institute under Government of NCT of Delhi

kirtisen@gmail.com9910609937

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026