Rithuximab in steroid-resistant nephrotic syndrome

Comparison of rituximab plus MMF with rituximab plus cyclosporine in children with steroid-resistant nephrotic syndrome.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150421021894N1

Enrollment

100

Registered

2019-03-25

Start date

2010-04-18

Completion date

Unknown

Last updated

2019-04-23

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

Conditions

Condition 1: Nephrotic syndrome. Condition 2: Nephrotic syndrome with focal and segmental glomerular lesion. Nephrotic syndrome Nephrotic syndrome with focal and segmental glomerular lesions

Interventions

Intervention 1: Interventional Group: Patients will receive Rituximab 375 mg/m2 weekly for 4 weeks plus mycophenolate mofetil 500 mg/m2 daily for 1 year. Intervention 2: Control group: Patients will

Eligibility

Sex/Gender

All

Age

1 Years to 12 Years

Inclusion criteria

Inclusion criteria: Idiopathic nephrotic syndrome Unresponsive to steroid, cyclophosphamide or mycophenolate mofetil therapy Active infection Leukopenia Immune deficiency syndrome Positive PPD test estimated GFR<90mL/min/m2 Patients ages between 1 and 12 years

Exclusion criteria

Exclusion criteria: Secondary nephrotic syndrome Lupus Diabetic Nephropathy

Design outcomes

Secondary

Measure	Time frame
Improved renal fnction. Timepoint: 12 months. Method of measurement: Measurement of glomerular filtration rate.	—

Primary

Measure	Time frame
Length of remission. Timepoint: 12 months. Method of measurement: Degree of proteinuria.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSimin Sadeghi

Zahedan University of Medical Sciences

sisadegh@yahoo.com+98 54 3329 5584

Outcome results

None listed

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