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

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ClinicalTrials.gov Identifier: NCT03501459
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Isaac Liu, National University Health System, Singapore

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

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: Rituximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
Study Start Date : June 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Rituximab Drug: Rituximab



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501459


Contacts
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Contact: Hui-Kim Yap hui_kim_yap@nuhs.edu.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Hui-Kim Yap       hui_kim_yap@nuhs.edu.sg   
Sponsors and Collaborators
National University Health System, Singapore

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Responsible Party: Isaac Liu, Professor Yap Hui Kim, National University Health System, Singapore
ClinicalTrials.gov Identifier: NCT03501459     History of Changes
Other Study ID Numbers: NMRC/NIG/0026/2008
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents