Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 1 November 2021
• Main ID: NCT01508468
• Date of registration: 09/12/2011
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy GEMRITUX
• Scientific title: Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN)
• Date of first enrolment: January 17, 2012
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01508468
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Karine Dahan, MD
• Affiliation: Assistance Publique

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Membranous Nephropathy

Intervention(s)

Drug: experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab)

Drug: symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin)

Primary Outcome(s)

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 ) [Time Frame: 6 months]

Secondary Outcome(s)

serologic diagnosis with identification of anti-NEP and anti-PLA2R antibodies in IMN before and after treatment with Rituximab [Time Frame: 6 months]

Effect of Rituximab on the progression of chronic renal disease [Time Frame: 6 months]

Evaluation of Rituximab tolerance in IMN [Time Frame: 6 months]

genetic analysis [Time Frame: 6 months]

Lymphocyte CD19 dosing at month 3 and month 6. [Time Frame: 6 months]

Secondary ID(s)

AOM 10089

P 100115

Source(s) of Monetary Support

Please refer to primary and secondary sponsors