- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501459
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
August 24, 2019 updated by: Isaac Liu, National University Health System, Singapore
The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui-Kim Yap
- Email: hui_kim_yap@nuhs.edu.sg
Study Locations
-
-
-
Singapore, Singapore
- Recruiting
- National University Hospital
-
Contact:
- Hui-Kim Yap
- Email: hui_kim_yap@nuhs.edu.sg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rituximab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response
Time Frame: 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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
April 10, 2018
First Submitted That Met QC Criteria
April 10, 2018
First Posted (Actual)
April 18, 2018
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 24, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMRC/NIG/0026/2008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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