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Rituximab in Refractory Primary Membranous Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880643
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Safak Mirioglu, Istanbul University

Brief Summary:
Primary membranous nephropathy (PMN), an autoimmune disease mostly associated with anti-phospholipase-A2-receptor (PLA2R) antibodies, is one of the most common causes of nephrotic syndrome in adults. In 30% to 40% of all cases, patients with PMN undergo spontaneous remission with conservative approaches. Corticosteroids, alkylating agents and calcineurin inhibitors are recommended treatment options in persistent disease activity despite supportive therapies. Nevertheless, patients with refractory disease constitute an important clinical aspect of PMN, and uncontrolled proteinuria may culminate in rapid progression to end-stage renal disease. In recent years, several studies demonstrated the efficacy of rituximab as a treatment option in patients with refractory PMN; however, data regarding daily clinical practice of this agent is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of rituximab in patients with refractory PMN.

Condition or disease
Glomerulonephritis, Membranous

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Efficacy and Safety of Rituximab in Patients With Refractory Primary Membranous Nephropathy
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Rituximab

Group/Cohort
Study Group
Patients with primary membranous nephropathy who were treated using rituximab (375 mg/m2/wk for 1-4 weeks) following resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.



Primary Outcome Measures :
  1. Complete Remission [ Time Frame: 6 months ]
    Proteinuria <0.3 g/day, confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.

  2. Partial Remission [ Time Frame: 6 months ]
    Proteinuria <3.5 g/day and a 50% or greater reduction from peak values, confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary membranous nephropathy who were treated using rituximab following resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.
Criteria

Inclusion Criteria:

  • Having biopsy-proven primary membranous nephropathy.
  • Showing resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.
  • Having a history of rituximab use (375 mg/m2/wk for 2-4 weeks) following resistance aforementioned agents.

Exclusion Criteria:

  • Not providing or withdrawing consent.

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): NCT03880643


Locations
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Turkey
Istanbul University
Istanbul, Turkey
Sponsors and Collaborators
Istanbul University
Investigators
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Study Chair: Halil Yazici, MD Department of Internal Medicine, Istanbul Faculty of Medicine
Principal Investigator: Safak Mirioglu, MD Department of Internal Medicine, Istanbul Faculty of Medicine
Publications:
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Responsible Party: Safak Mirioglu, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT03880643    
Other Study ID Numbers: 2018/1509
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Safak Mirioglu, Istanbul University:
membranous nephropathy
rituximab
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis
Glomerulonephritis, Membranous
Urologic Diseases
Nephritis
Autoimmune Diseases
Immune System Diseases