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

N

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)

100 participants in 1 patient group

Rituximab
Experimental group
Treatment:
Drug: Rituximab

Trial contacts and locations

1

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Central trial contact

Hui-Kim Yap

Data sourced from clinicaltrials.gov

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