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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 31 July 2012
Main ID:  EUCTR2011-006115-59-IT
Date of registration: 08/06/2012
Prospective Registration: Yes
Primary sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Public title: "A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN)"
Scientific title: "A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN)" - GNM-2011
Date of first enrolment: 11/06/2012
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006115-59
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Italy
Contacts
Name: coordinamento ricerca clinica   
Address:  p.le spedali civili 1 25125 brescia Italy
Telephone: 0303996851
Email: carmen.terraroli@spedalicivili.brescia.it
Affiliation:  AO Spedali Civili di Brescia
Name: coordinamento ricerca clinica   
Address:  p.le spedali civili 1 25125 brescia Italy
Telephone: 0303996851
Email: carmen.terraroli@spedalicivili.brescia.it
Affiliation:  AO Spedali Civili di Brescia
Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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 Classification code 10018372 Term: Glomerulonephritis membranous System Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Intervention(s)

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-

Trade Name: URBASON*IM EV 1F 250MG+1F 5ML
Pharmaceutical Form: Solution for infusion
CAS Number: 83-43-2
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: MEDROL*10CPR DIV 4MG
Pharmaceutical Form: Tablet
CAS Number: 83-43-2
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: .4-

Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG
Pharmaceutical Form: Coated tablet
CAS Number: 50-18-0
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: .2-

Primary Outcome(s)
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).
Primary end point(s): The primary outcome was the difference in the probability of complete remission (proteinuria <0.3 g / day) at one year
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.
Timepoint(s) of evaluation of this end point: one year
Secondary Outcome(s)
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
Secondary ID(s)
GNM-2011
Source(s) of Monetary Support
Azienda Spedali Civili di Brescia
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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