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A clinical trial comparing daily versus alternate day prednisolone in children with nephrotic syndrome.

Randomized controlled trial to compare the efficacy of low-dose daily versus alternate-day prednisolone in children with steroid dependent and frequently relapsing nephrotic syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024596
Enrollment
38
Registered
2020-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes

Interventions

Intervention1: daily low dose (0.15-0.25mg/kg): After allotment in this group the subjects will be given steroid in low dose daily 0.15mg/kg-0.25mg/kg(intervention group). Control Intervention1: alter

Sponsors

Jawaharlal Nehru Medical College
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Age at onset of nephrotic syndrome 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.

Design outcomes

Primary

MeasureTime frame
Relapse frequency.Timepoint: At Enrolment,At 1 year

Secondary

MeasureTime frame
1. safety (side effect of corticosteroids) 2. Time to first relapse 3. Proportion of patients relapse-free 4. Cumulative steroid dose used 5. Infection episodes 6. Need for alternative medications.Timepoint: 3 monthly during 1 year followup

Countries

India

Contacts

Public ContactZulquarnain

Jawaharlal Nehru Medical College,AMU

drkafzal@hotmail.com0571-2721182

Outcome results

None listed

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