Rituximab in Refractory Primary Membranous Nephropathy
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|ClinicalTrials.gov Identifier: NCT03880643|
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : November 13, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Efficacy and Safety of Rituximab in Patients With Refractory Primary Membranous Nephropathy|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||May 31, 2019|
|Actual Study Completion Date :||September 30, 2019|
Patients with primary membranous nephropathy who were treated using rituximab (375 mg/m2/wk for 1-4 weeks) following resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.
- Complete Remission [ Time Frame: 6 months ]Proteinuria <0.3 g/day, confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.
- Partial Remission [ Time Frame: 6 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.
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): NCT03880643
|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|