Back to resultsLymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
Primary Purpose
Nephrotic Syndrome
Status
Recruiting
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Nephrotic Syndrome
Eligibility 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.
Sites / Locations
- National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03501459
First Posted
April 10, 2018
Last Updated
August 24, 2019
Sponsor
National University Health System, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03501459
Brief Title
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
Official Title
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Health System, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab
Primary Outcome Measure Information:
Title
Response
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Kim Yap
Email
hui_kim_yap@nuhs.edu.sg
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Kim Yap
Email
hui_kim_yap@nuhs.edu.sg
12. IPD Sharing Statement
Learn more about this trial
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
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