MEmbranous Nephropathy Trial Of Rituximab (MENTOR)
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|ClinicalTrials.gov Identifier: NCT01180036|
Recruitment Status : Active, not recruiting
First Posted : August 11, 2010
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Membranous Nephropathy||Drug: Rituximab Drug: Cyclosporine||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||"A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN)"|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||October 1, 2017|
|Estimated Study Completion Date :||October 2019|
Active Comparator: Rituximab Treatment Arm
Patients randomized to the RTX arm will receive 1000 mg IV on Days 1 and 15. Patients who achieve complete remission at 6 months will not be retreated. A second course of RTX 1000 mg IV will be administered at study month 6 for individuals who have not achieved a complete remission, but have achieved a minimum of >25% reduction in Time 0 proteinuria. Dosing at study month 6 will be independent of CD19+ B cell count.
1000 mg, I.V. on Days 1 and 15 and will be retreated at month 6 independent of CD19+ B cell count
Other Name: Rituxan, MabThera
Active Comparator: Cyclosporine Treatment Arm
Patients randomized to the Cyclosporine arm will be started at a dose of CsA = 3.5 mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Target trough CsA blood levels are 125 to 175 ng/ml. Patients will have their doses adjusted according to their blood levels of CSA as monitored every 2 weeks until the target trough level is reached. If a complete remission is achieved by 6 months, CSA will be tapered and discontinued over a three-month period. If after 6 months there has not been a reduction in proteinuria of at least 25% of baseline values, the drug will also be discontinued. If there has been a >25% reduction in baseline proteinuria (but not complete remission) the CSA will be continued for an additional 6 months.
Patients randomized to the Cyclosporine arm will be started at a dose of (CsA = 3.5 mg/kg/day p.o. divided into 2 doses for 12 months). Target trough CsA blood levels, as determined in whole blood by HPLC, are 125 to 175 ng/ml. A persistent and otherwise unexplained increase in serum creatinine >30% would prompt an approximate 25% dose reduction of CSA, aiming for a corresponding 25% reduction in CSA trough level. If with this dose reduction the creatinine does not return to within 30% of baseline levels within 3 weeks, then a second dose reduction of approximately 25% with similar reduction in CSA trough level will be used. If the creatinine does not fall to baseline values with this second dose reduction, the drug will be discontinued. At the end of 12 months, Cyclosporine will be tapered by 1/3 of the maintenance dose monthly and hence discontinued after 3 months.
Other Name: Sandimmune
- Remission status [ Time Frame: 24 months after randomization ]Complete remission or partial remission at 24 months after randomization will be the primary endpoint.
- Remission Status [ Time Frame: 6-24 months after randomization ]Relapse state at month 24 after randomization (Urine Protein) (UP) >3.5 after earlier CR or PR; CR(Complete Remission) or PR (Partial Remission), and CR alone at 6, 12, 18, and 24 after randomization; Time to CR or PR; Anti-PLA2R levels; Quality of life as measured by modified KDQOL; Adverse events; ESRD
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): NCT01180036
Show 21 Study Locations
|Principal Investigator:||Fernando C. Fervenza, M.D., Ph.D.||Mayo Clinic|