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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04369183
Other study ID # 2019/977
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date October 31, 2020

Study information

Verified date November 2020
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date October 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ruggenenti P, Ruggiero B, Cravedi P, Vivarelli M, Massella L, Marasà M, Chianca A, Rubis N, Ene-Iordache B, Rudnicki M, Pollastro RM, Capasso G, Pisani A, Pennesi M, Emma F, Remuzzi G; Rituximab in Nephrotic Syndrome of Steroid-Dependent or Frequently Relapsing Minimal Change Disease Or Focal Segmental Glomerulosclerosis (NEMO) Study Group. Rituximab in steroid-dependent or frequently relapsing idiopathic nephrotic syndrome. J Am Soc Nephrol. 2014 Apr;25(4):850-63. doi: 10.1681/ASN.2013030251. Epub 2014 Jan 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Remission 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. 12 months
Primary Partial Remission 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. 12 months
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