MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hyp MedDRA version: 14.1 Level: PT Clas
Conditions
Interventions
Trade Name: MABTHERA*EV 1FL 50ML 500MG
Pharmaceutical Form: Solution for injection
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trad
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Biopsy diagnosis of idiopathic MN, performed in the last 24 months 2. Proteinuria> 3.5 g/24h in three measurements (one measurement for 3 weeks) 3. Estimated GFR (MDRD formula) = 50ml/min/1.73m2 treated with ACE inhibitors / ARBs 4. Physiological or surgically menopausal women, women who implement an approved method of contraception 5. Failure in treatment with ACE inhibitors or ARBs to be first 3 months of treatment with RTX Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Serum creatinine> 2.0mg/dl; eGFR <50 ml/min/1.73m2, 2. Previous treatment with rituximab, steroids, alkylating agents, calcineurin inhibitor, ACTH, MMF, azathioprine 3. Presence of active infection 4. Secondary causes of MN (eg hepatitis B, SLE, drugs, tumors). Testing for HIV, hepatitis B and C run less than 6 months before study 5. Diabetes mellitus type 1 and 2 6. Pregnancy or breast-feeding for safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome was the difference in the probability of complete remission (proteinuria <0.3 g / day) at one year (see design and power considerations).;Secondary Objective: Differences in terms of: Levels of proteinuria at time 0, 6.12, 18, 24 and 36 months; Composite end point of CR (complete remission) or PR (partial remission) at 6, 12, 18, 24, and 36 months; Mortality '; Estimated glomerular filtration rate (MDRD formula) at 6, 12, 18, 24, and 36 months; Value of serum creatinine (mg / dl) at 6, 12, 18, 24, and 36 months; Frequency and number of relapses; Frequency of autoantibodies anti-phospholipase A2 receptor (anti-PLA2R), anti-superoxide dismutase 2 (SOD2 anti-), anti-aldose reductase (anti-AR), anti-alpha-enolase (anti-a-enolase) at time 0 and after 3, 6.12, 18, 24 and 36 months after therapy.;Primary end point(s): The primary outcome was the difference in the probability of complete remission (proteinuria <0.3 g / day) at one year;Timepoint(s) of evaluation of this end point: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Differences in terms of: Levels of proteinuria at time 0, 6.12, 18, 24 and 36 months; Composite end point of CR (complete remission) or PR (partial remission) at 6, 12, 18, 24, and 36 months; Mortality '; Estimated glomerular filtration rate (MDRD formula) at 6, 12, 18, 24, and 36 months; Value of serum creatinine (mg / dl) at 6, 12, 18, 24, and 36 months; Frequency and number of relapses; Frequency of autoantibodies anti-phospholipase A2 receptor (anti-PLA2R), anti-superoxide dismutase 2 (SOD2 anti-), anti-aldose reductase (anti-AR), anti-alpha-enolase (anti-a-enolase) at time 0 and after 3, 6.12, 18, 24 and 36 months after therapy.;Timepoint(s) of evaluation of this end point: three years | — |
Countries
Italy
Contacts
Public Contactcoordinamento ricerca clinica
AO Spedali Civili di Brescia
Outcome results
None listed