Using lymphocyte markers to predict response to rituximab in children with nephrotic syndrome
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
This study is testing if certain blood markers can help predict how well children with nephrotic syndrome will respond to rituximab treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | National University Health System, Singapore Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Singapore) |
| Trial ID | NCT03501459 on ClinicalTrials.gov |
What this trial studies
This study investigates whether specific lymphocyte markers can predict how well patients with idiopathic nephrotic syndrome respond to rituximab treatment. It focuses on children aged 1 to 18 years who are either steroid-dependent or steroid-resistant. By analyzing these markers, the study aims to identify which patients are more likely to benefit from rituximab, potentially leading to more personalized treatment approaches. The trial is interventional and is classified as a Phase 3 study.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1-18 years diagnosed with steroid-dependent or steroid-resistant nephrotic syndrome.
Not a fit: Patients with nephrotic syndrome secondary to other conditions or with certain genetic mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and tailored treatments for children suffering from nephrotic syndrome.
How similar studies have performed: While the approach of using lymphocyte markers to predict treatment response is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Singapore
- National University Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Hui-Kim Yap
- Email: hui_kim_yap@nuhs.edu.sg
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.