Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

The IMN exposes patients to severe complications which engage the vital prognosis or Nephrotic Syndrome. The development of well tolerated and effective pathogenesis linked therapies is needed to treat patients with idiopathic Membranous Nephropathy Rituximab, a monoclonal antibody (mAb) against the CD20 present on B cells, 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. However, no randomized controlled study has been published to date. In a previous study, outcome of 28 patients treated with rituximab for idiopathic MN is analysed. Anti-PLA2R antibodies in serum and PLA2R antigen in kidney biopsy were assessed in 10 and 9 patients. Proteinuria was significantly decreased by 56%, 62% and 87% at 3 months, 6 months and 12 months. At 6 months, 2 patients achieved full remission and 12 partial remission (overall renal response, 50%). At 12 months (n=23), complete remission was achieved in 6 patients and partial remission in 13 patients (overall renal response, 82,6%). Three patients suffered a relapse of nephrotic proteinuria 27 to 50 months after treatment. Univariate analysis suggested that the degree of renal failure (MDRD < 45/ml/min/1.73 m²) is an independent factor that predicts lack of response to rituximab. Anti-PLA2R antibodies were detected in serum in 10 patients, and PLA2R antigen in immune deposits in 8 of 9 patients. Antibodies became negative in all 5 responsive patients with available follow-up. In this retrospective study, a high rate of remission was achieved at 12 months after treatment. Our trial is a Prospective randomized multicentric open label study. The 2 arms of the study are : Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab+ NIST Patients randomized to the Rituximab arm will receive 375 mg/m² on days 1 and 8 (+ NIST). Patients in the control arm will be treated only with Non Immunosuppressive Symptomatic Treatment (NIST). The duration of participation per patient is 6 months for interventional study. An observational follow-up is performed at M9, M12, M18 & M24 for all patients included in study with lab data collection of test done during usual pathology follow-up. A part of the diagnosis renal biopsy (performed usually as part of health care) is collected for all patients as for the purpose of central analysis. Our Primary Outcome Measure is evaluation of efficacy of Rituximab associated with NIST in (IMN) in reducing the rate of proteinuria (patients with persistent urinary protein excretion rate ≥3,5g/24 h and albuminemia < 30g/l ). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01508468
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 3
Start date January 17, 2012
Completion date August 31, 2016

See also
  Status Clinical Trial Phase
Recruiting NCT06245707 - the Effects of Different Treatment Schemes on Cognitive Function of Patients With Idiopathic Membranous Nephropathy N/A
Recruiting NCT03864250 - Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy N/A
Completed NCT01180036 - MEmbranous Nephropathy Trial Of Rituximab Phase 2/Phase 3
Completed NCT01845688 - Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy N/A
Withdrawn NCT01093781 - Aliskiren in Patients With Idiopathic Membranous Nephropathy N/A
Completed NCT00362531 - Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome Phase 2/Phase 3
Recruiting NCT05839314 - Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy Phase 4
Completed NCT00302523 - Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy N/A
Terminated NCT03466801 - The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I. N/A
Terminated NCT03475602 - Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy
Not yet recruiting NCT05850845 - Study on the Application of Hyperspectral Imaging Technique in CTX Treatment of IMN
Not yet recruiting NCT05667883 - Prognostic Model of GC/CTX in the Treatment of MN
Not yet recruiting NCT05667922 - Prognostic Model of TAC in the Treatment of MN
Not yet recruiting NCT05667896 - Prognostic Model of GC/TAC in the Treatment of MN
Not yet recruiting NCT05667909 - Prognostic Model of Rituximab in the Treatment of MN
Recruiting NCT02173106 - A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy Phase 2
Completed NCT01161459 - Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid N/A
Recruiting NCT03549663 - Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN) N/A
Not yet recruiting NCT05845762 - Obinutuzumab in the Management of Idiopathic Membranous Nephropathy
Completed NCT00694863 - Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy Phase 2