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Effect of one dose versus two dose injection Rituximab in children with steroid dependent nephrotic syndrome aged between 3-12 years who are difficult to treat with other medications.

Effectiveness of single dose versus dual dose Rituximab in difficult-to-treat, steroid dependent nephrotic syndrome in children: A single blind Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096461
Enrollment
60
Registered
2025-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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: Administration of single dose Rituximab: Patients will receive single dose of injection Rituximab 375 mg/m2 in the first week. In week 2 they will receive placebo normal saline. Contr

Sponsors

Renaissa Banik
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All pediatric patients diagnosed with difficult to treat SDNS attending OPD/ IPD of department of pediatrics, IPGME&R aged 3 years to 12 years

Exclusion criteria

Exclusion criteria: Congenital nephrotic syndrome patients, aged less than 3 months Nephrotic syndrome secondary to causes like , sickle cell disease, HIV, systemic lupus erythematosus, hepatitis B, malaria, parvovirus B19, medications Patients with Hep B core antibody total positive, since Rituximab can lead to reactivation of latent hepatitis B virus. Incomplete records Did not give consent

Design outcomes

Primary

MeasureTime frame
We anticipate that single-dose Rituximab (375 mg/m²) will be non-inferior to double-dose Rituximab( two doses of 375mg/m2 given in 1week interval) in maintaining relapse-free remission in children with difficult-to-treat steroid-dependent nephrotic syndrome (SDNS). The time to first relapse and the number of relapses in a year will be similar between the single-dose and double-dose groups. Timepoint: 18 months—

Secondary

MeasureTime frame
1. Reduction in cumulative steroid exposure will be similar between both groups, indicating effective steroid-sparing action even with a single dose. 2. B-cell depletion and reconstitution timelines may differ, but without a significant impact on clinical remission rates. 3. The relapse rates at 6 months and 12 months will not differ significantly between the two groups. 4. The single-dose group is expected to have a lower incidence of hypogammaglobulinemia. Timepoint: 18 months—

Countries

India

Contacts

Public ContactAtanu Roy

IPGMER and SSKMH

atanuroy76@gmail.com9735362437

Outcome results

None listed

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