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

Phase 3

Recruiting

• Conditions: Nephrotic Syndrome
• Interventions: Drug: Rituximab

• Registration Number: NCT03501459
• Lead Sponsor: National University Health System, Singapore

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-24
• Last Update Posted: 2019-08-28
• Primary Completion: 2020-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab	Rituximab	-

Primary Outcome Measures

Name	Time	Method
Response	3 months	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.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore