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Efficacy of Rituximab with half dose steroid when compared to full dose steroids alone as initial therapy in patients with minimal change nephrotic syndrome

Low dose Rituximab along with half dose steroids as initial therapy in minimal change nephrotic syndrome - A randomized controlled trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112895
Enrollment
134
Registered
2026-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality

Interventions

Intervention1: Rituximab with half dose steroids: Patients will be treated with two doses of Inj. Rituximab (375mg/m2 BSA) two weeks apart (Day1 and Day15) with premedication of 100mg Inj. Methylpredn

Sponsors

Madras medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children aged 2 12 years with newly diagnosed nephrotic syndrome (as per KDIGO) and no family history 2.Patients aged more than 12 years with newly diagnosed nephrotic syndrome with renal biopsy diagnosis of minimal change disease. 3.eGFR more than 60ml/min/1.73m2 (CKD-EPI equation)

Exclusion criteria

Exclusion criteria: 1.Age less than 2 years and over 60 years 2.Patients with pre-existing kidney disease 3.Positive family history 4.History of native medication intake 5.History of steroid or any other immunosuppression intake in past 3 months 6.Active infection, malignancy 7.Patients with contraindications to steroids / rituximab

Design outcomes

Primary

MeasureTime frame
Number of patients who achieve complete remission or partial remissionTimepoint: 16 weeks

Secondary

MeasureTime frame
number of patients who remain relapse free in follow-up, time to first relapse, reduction in cumulative steroid dose and toxicityTimepoint: 1 year

Countries

India

Contacts

Public ContactGurumoorthy A D

Madras Medical College

draatral@gmail.com9444126080

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026