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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03501459
Date of registration: 10/04/2018
Prospective Registration: No
Primary sponsor: National University Health System, Singapore
Public title: Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
Scientific title: Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
Date of first enrolment: June 2008
Target sample size: 100
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03501459
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Singapore
Contacts
Name:     Hui-Kim Yap
Address: 
Telephone:
Email: hui_kim_yap@nuhs.edu.sg
Affiliation: 
Name:     Hui-Kim Yap
Address: 
Telephone:
Email: hui_kim_yap@nuhs.edu.sg
Affiliation: 
Key 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.



Age minimum: 1 Year
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Nephrotic Syndrome
Intervention(s)
Drug: Rituximab
Primary Outcome(s)
Response [Time Frame: 3 months]
Secondary Outcome(s)
Secondary ID(s)
NMRC/NIG/0026/2008
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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