Personalized Medicine for Membranous Nephropathy PMM

Phase 1

• Conditions: Idiopathic Membranous Nephropathy; MedDRA version: 20.0 Level: LLT Classification code 10027170 Term: Membranous nephropathy System Organ Class: 100000004857; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2018-002476-40-FR
• Lead Sponsor: CHU de Nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

-Age 18 years or more
-Anti-PLA2R1 activity detected by ELISA or Euroimmune IFA
-Nephrotic syndrome defined by proteinuria > 3.5 g/24h (or UPCR > 3.5 g/g) and serum albumin < 30 g/L at diagnosis
-eGFR (CKD-EPI) > 30 ml/min/1,73 m2 at diagnosis
-Symptomatic treatment according to KDIGO guidelines: maximal tolerated dose of NIAT (angiotensin-converting enzyme inhibitor and/or angiotensin 2 receptor blockers, diuretics and statins)
-Medical insurance
-Signed informed consent
-Having understood and accepted the need for long-term medical follow-up
-Woman of child-bearing age must be using an effective method of contraception

Are the trial subjects under 18? no
Number of subjects for this age range:
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 4

Exclusion Criteria

-Secondary MN: MN related to cancer, infectious, systemic lupus erythematosis, drug
-Anti-PLA2R1 antibodies not confirmed by central analysis (in this case the patient will be replaced)
-Pregnancy or breastfeeding
-Immunosuppressive treatment in the 3 last months
-Cancer under treatment
-Patient with complicated nephrotic syndrome that would require early immunosuppressive treatment (thrombosis, acute renal failure…)
-Patients with active, severe infections or active hepatitis B
-Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
-Patients in a severely immunocompromised state
-Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
-Patients unable to give an informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified