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Rituximab for Refractory or Relapsed Focal Segmental Glomerulosclerosis or Minimal Change Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369183
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Safak Mirioglu, Istanbul University

Brief Summary:
Various studies have been conducted to identify effective treatment strategies for primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) so far. In the light of these studies, corticosteroids and calcineurin inhibitors have been the treatment of choice and mycophenolic acid derivatives have been seen as a second line agent. However, treatment options in refractory or relapsed cases are still under debate. Recently, rituximab has become an alternative in those patients. Therefore, a study based on registry data was conducted to evaluate the efficacy and safety of rituximab in adult patients suffering from a relapsed or refractory primary FSGS or MCD.

Condition or disease
Focal Segmental Glomerulosclerosis Minimal Change Disease

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Efficacy and Safety of Rituximab in Adult Patients With Refractory or Relapsed Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 31, 2020


Group/Cohort
Study Group
Patients with primary focal segmental glomerulosclerosis or minimal change disease who were treated using rituximab (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives.



Primary Outcome Measures :
  1. Complete Remission [ Time Frame: 12 months ]
    Proteinuria <0.5 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: 12 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 to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary focal segmental glomerulosclerosis or minimal change disease who were treated using rituximab following resistance to or relapse after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives.
Criteria

Inclusion Criteria:

  • Having biopsy-proven focal segmental glomerulosclerosis or minimal change disease.
  • Showing resistance to or relapsing after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives.
  • Having a history of rituximab use (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after 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): NCT04369183


Contacts
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Contact: Safak Mirioglu, MD +902124142000 ext 32149 smirioglu@gmail.com
Contact: Halil Yazici, MD

Locations
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Turkey
Istanbul University Recruiting
Istanbul, Turkey
Contact: Safak Mirioglu, MD         
Contact: Halil Yazici, MD         
Sub-Investigator: Erdem Gurel, MD         
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: NCT04369183    
Other Study ID Numbers: 2019/977
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
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:
focal segmental glomerulosclerosis
minimal change disease
rituximab
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Nephrosis, Lipoid
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Nephrosis