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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03501459
Enrollment
100
Registered
2018-04-18
Start date
2008-06-30
Completion date
2025-12-31
Last updated
2019-08-28

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

Conditions

Nephrotic Syndrome

Brief summary

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

Interventions

DRUGRituximab

Sponsors

National University Health System, Singapore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Response3 monthsResolution 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.

Countries

Singapore

Contacts

Primary ContactHui-Kim Yap
hui_kim_yap@nuhs.edu.sg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026