Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome

National University Health System, Singapore

Status and phase: Enrolling; Phase 3

Conditions: Nephrotic Syndrome

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT03501459

NMRC/NIG/0026/2008

Details and patient eligibility

About

The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome

Enrollment: 100 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 1-18 years old at the time of diagnosis of nephrotic syndrome
• Steroid-dependent (SDNS) or steroid-resistant nephrotic syndrome (SDNS)

Exclusion criteria

• eGFR <60 ml/min per 1.73m2
• infantile onset of nephrotic syndrome
• nephrotic syndrome secondary to chronic infections such as hepatitis B, hepatitis C or human immunodeficiency virus, systemic lupus erythematosus, Henoch-Schönlein purpura, IgA nephropathy, membranoproliferative glomerulonephritis or membranous nephropathy
• current or previous therapy for tuberculosis
• presence of mutations in WT1, NPHS1, NPHS2 and TRPC6.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Rituximab

Experimental group

Treatment:

Drug: Rituximab