Clinical trial NCT04369183: Rituximab for Refractory or Relapsed Focal Segmental Glomerulosclerosis or Minimal Change Disease
Official title: Efficacy and Safety of Rituximab in Adult Patients With Refractory or Relapsed Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focal Segmental Glomerulosclerosis
Minimal Change Disease
Keywords: focal segmental glomerulosclerosis
minimal change disease
rituximab
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Complete Remission
timeFrame: 12 months
measure: Partial Remission
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Department of Internal Medicine, Istanbul Faculty of Medicine
name: Halil Yazici, MD
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Istanbul Faculty of Medicine
name: Safak Mirioglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruggenenti P, Ruggiero B, Cravedi P, Vivarelli M, Massella L, Marasa 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.