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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Halil Yazici, MD | Department of Internal Medicine, Istanbul Faculty of Medicine | Study Chair |
| Safak Mirioglu, MD | Department of Internal Medicine, Istanbul Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24480824 | Background | 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. |
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| ID | Term |
|---|---|
| D005923 | Glomerulosclerosis, Focal Segmental |
| D009402 | Nephrosis, Lipoid |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009401 | Nephrosis |