Efficacy and Safety of Rituximab in Adult Patients With Refractory or Relapsed Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Sponsor study identifier
observational
25
1 country
1
Study Start
September 1, 2019
Actual (reported)Primary Completion
August 31, 2020
Actual (reported)Study Completion
October 31, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2019
Actual (reported)April 25, 2020
Actual (reported)April 30, 2020
Actual (reported)August 31, 2020
Actual (reported)October 31, 2020
Actual (reported)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
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
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.
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.
Istanbul University
Istanbul, Turkey (Türkiye)
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.
Halil Yazici, MD
Department of Internal Medicine, Istanbul Faculty of Medicine
Safak Mirioglu, MD
Department of Internal Medicine, Istanbul Faculty of Medicine
25 participants (actual enrollment reported by the registry).
First Submitted
April 25, 2020
First Posted
April 30, 2020
Study Start
September 1, 2019
Actual (reported)Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome
Contact the study team to confirm eligibility.
Primary Completion
August 31, 2020
Actual (reported)Study Completion
October 31, 2020
Actual (reported)Last Updated
December 1, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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