Idiopathic Membranous Nephropathy Clinical Trial
— GEMRITUXOfficial title:
Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN)
Verified date | October 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Membranous Nephropathy is one of the most common cause of Nephrotic Syndrome of adults. In 2/3 of patients the cause of the disease is idiopathic. This can also be referred to as idiopathic membranous nephropathy (IMN).The most of these patients are treated by non immunosuppressive symptomatic treatment (NIST): antiproteinuric and antihypertensive blocking the rennin-angiotensine system. However, the patients resistant to antiproteinuric treatment risk to develop an end stage renal disease (ESRD). Rituximab has been recently used in patients suffering of nephrotic syndrome related to IMN in four international studies. Rituximab appears effective and safe in reducing proteinuria in nearly 60% of patients. The primary outcome of the investigators prospective randomized study is to determine whether or not the Rituximab associated with NIST is more effective than non immunologic symptomatic treatment alone in inducing long term remission of proteinuria.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 31, 2016 |
Est. primary completion date | August 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - At least 18 years old. - Idiopathic Membranous nephropathy proved by renal biopsy - Persistent urinary protein excretion rate =3,5g/24 h and albuminemia < 30g/l for at least 6 months with full dose of NIST - Patient receiving a non immunosuppressive conventional treatment (antiproteinuric and antihypertensive blocking the rennin-angiotensine system, lipid-lowering statin) since at least 6 months. - Patient has given its written consent - Patient with social coverage (excepting AME) - Use of an efficient contraception method for women in childbearing age. Exclusion Criteria: - Secondary membranous nephropathy - Patient already in a clinical trial - Patient received an immunosuppressive treatment within 3 months before the study - Patient with chronic renal disease defined by estimated GFR by MDRD formula under 30ml/mn/1,73m² - Pregnancy and breastfeeding - HIV infection, HCV and HBV active infection - Severe or evolving infections. - Allergy or hypersensitivity to Rituximab or any component |
Country | Name | City | State |
---|---|---|---|
France | Department of Nephrology , Tenon hospital - APHP | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of efficacy of Rituximab associated with Non Immunosuppressive Symptomatic Treatment (NIST) in (IMN) in reducing the rate of proteinuria (patients with persistent urinary protein excretion rate =3,5g/24 h and albuminemia < 30g/l ) | Evaluation of efficacy of Rituximab associated with Non Immunosuppressive Symptomatic Treatment (NIST) in (IMN) in reducing the rate of proteniuria | 6 months | |
Secondary | Effect of Rituximab on the progression of chronic renal disease | Effect of Rituximab on the progression of chronic renal disease by measuring :
Percentage of proteinuria variation at 6 months Percentage of nephrotic syndrome complication: measuring serum creatinine and glomerular filtration rate (GFR) at 6 months, infections, hydrops, vein thrombosis, arterial thrombosis. |
6 months | |
Secondary | Evaluation of Rituximab tolerance in IMN | Evaluation of Rituximab tolerance in IMN :
-Percentage of serious allergic reaction after Rituximab infusion "drop in blood pressure and/or bronchospasm" |
6 months | |
Secondary | serologic diagnosis with identification of anti-NEP and anti-PLA2R antibodies in IMN before and after treatment with Rituximab | serologic diagnosis with identification of anti-NEP and anti-PLA2R antibodies in IMN before and after treatment with Rituximab | 6 months | |
Secondary | genetic analysis | genetic analysis Study of the alleles "HLA-DQA1 and PLA2R1" situated respectively on chromosomes 6p21 and 2q24. | 6 months | |
Secondary | Lymphocyte CD19 dosing at month 3 and month 6. | Lymphocyte CD19 dosing at month 3 and month 6. | 6 months |
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