A study to compare response to treatment with a combination of two medications, namely tacrolimus and rituximab, compared to only tacrolimus, for nephrotic syndrome that does not respond to steroids

A pilot open label RCT to examine the superiority of the combination of tacrolimus and rituximab versus tacrolimus alone in inducing complete remission in patients with steroid resistant nephrotic syndrome - Nil

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081825

Enrollment

Registered

2025-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: N041- Nephrotic syndrome with focal andsegmental glomerular lesions Health Condition 2: N040- Nephrotic syndrome with minor glomerular abnormality

Interventions

Intervention1: Combination of oral tacrolimus and IV rituximab: 1. Tacrolimus in an oral dose of 0.1-0.2 mg/kg in two divided doses daily x 3 months, and 2. IV rituximab, at a dose of 375 mg/m2 2 dos

as short IV infusion over 4-6 hr, following premedication, in daycare as per protocol Control Intervention1: Oral tacrolimus: Tacrolimus shall be given in an oral dose of 0.1-0.2 mg/kg in two divided

Eligibility

Inclusion criteria

Inclusion criteria: Children with newly diagnosed idiopathic steroid resistant nephrotic syndrome, aged 4 - 18 years, with initial or late steroid resistance and histology indicating minimal change disease or focal segmental glomerulosclerosis (FSGS), in partial remission or with non-response following 3-months of adequate therapy with tacrolimus

Exclusion criteria

Exclusion criteria: Known or suspected monogenic SRNS (initial SRNS with syndromic features or familial SRNS with non-response to immunosuppression) Secondary NS (membranoproliferative GN, IgA nephropathy, lupus) Chronic infection with hepatitis B or C or human immunodeficiency virus Post-transplant recurrence of NS Estimated glomerular filtration rate (eGFR) less than 60 mL/min per 1.73 m2, persistently (on more than 2 occasions at least 2-weeks apart) Prior therapy with rituximab (for steroid-dependent disease course) in the last 1 year Moderate to severe hypogammaglobulinemia, lymphopenia or leukopenia Clinically diagnosed infection within the last 1 week Refusal of consent

Design outcomes

Primary

Measure	Time frame
The primary outcome is to estimate the proportions with complete remissionTimepoint: 3 months	—

Secondary

Measure	Time frame
Proportions with non-response and partial remission to therapyTimepoint: 3 months;The percentage reduction in proteinuria From true baseline (at start of therapy with CNI) and from randomization (at 3-months therapy with CNI)Timepoint: 3 months;The proportions with treatment emergent adverse events (TEAE), including serious AE, their severity (CTCAE) and causality association (WHO-UMC)Timepoint: 3 months;The proportions of patients with new-onset hypogammaglobulinemia, acute kidney injury, leukopenia or neutropeniaTimepoint: 3 months	—

Measure

Time frame

Proportions with non-response and partial remission to therapyTimepoint: 3 months;The percentage reduction in proteinuria From true baseline (at start of therapy with CNI) and from randomization (at 3-months therapy with CNI)Timepoint: 3 months;The proportions with treatment emergent adverse events (TEAE), including serious AE, their severity (CTCAE) and causality association (WHO-UMC)Timepoint: 3 months;The proportions of patients with new-onset hypogammaglobulinemia, acute kidney injury, leukopenia or neutropeniaTimepoint: 3 months

—

Countries

India

Contacts

Public ContactAditi Sinha

All India Institute of Medical Sciences

aditisinhaaiims@gmail.com9899145489

Outcome results

None listed

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