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Study to determine whether two drugs are better than one in treatment of difficult to treat nephrotic syndrome

An open label randomised control trial comparing between solo prednisolone therapy versus steroid-sparing agent along with daily doses of prednisolone in achievement of remission among FRNS and SDNS patients - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065552
Enrollment
120
Registered
2024-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: N04- Nephrotic syndrome

Interventions

Intervention1: SSA with Prednisolone: 1. Syp Cyclosporine (100mg/ml) @ 5 mg/kg/day (max dose 250 mg) in divided doses or 2. Tab Tacrolimus 0.2 mg/kg/day (maximum 10 mg) in 2 divided doses or 3. Tab My

Sponsors

SCB Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Frequently relapsing nephrotic syndrome patients aged 1-14 years. 2. Steroid-dependent nephrotic syndrome patients aged 1-14 years requiring SSA. 3. Any nephrotic patient on SSA. 4. At least 6 months of follow-up from the time of enrollment in the study.

Exclusion criteria

Exclusion criteria: 1. Children who have secondary cause for FRNS/SDNS. 2. SRNS, infantile and congenital NS. 3. Children who have received Rituximab six months prior to enrollment into the study. 4. Children already on prednisolone therapy.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of early initiation of steroid-sparing agents with daily dose of prednisolone compared to only prednisolone therapy in achieving remission among patients aged 1-14 years diagnosed with FRNS/SDNS.Timepoint: 6 months

Secondary

MeasureTime frame
To compare any increase in the risk of serious infection associated with the two different approaches in these children.Timepoint: 6 months;To observe the number of relapses in both intervention arms.Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Aishwarya Chandra

SCB Medical College and Hospital

drsubal@rediffmail.com9777860915

Outcome results

None listed

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