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NCT03501459 Clinical Trial

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

Nephrotic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03501459
Other study ID # NMRC/NIG/0026/2008
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 2008
Est. completion date December 2025

Study information
Verified date August 2019
Source National University Health System, Singapore
Contact Hui-Kim Yap
Email hui_kim_yap@nuhs.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rituximab

Locations
Country Name City State
Singapore National University Hospital Singapore

Sponsors (1)
Lead Sponsor Collaborator
National University Health System, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response Resolution of proteinuria (urine protein:creatinine <0.02 g/mmol or urine protein excretion <0.3 g/1.73m2/day) and ability to wean off prednisolone and calcineurin inhibitor at three months after the last dose of rituximab. 3 months
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