Eculizumab in Primary MPGN

Phase 2CompletedNCT02093533

Mario Negri Institute for Pharmacological Research10 enrolled

Overview

Membranoproliferative glomerulonephritis (MPGN) is the third or fourth leading cause of end stage renal disease among the primary glomerulonephritis. Hyperactivation of the alternative complement pathway and familial forms for all types of MPGN have been reported suggesting that genetic abnormalities may play a predisposing role to the disease. In recent case reports Eculizumab, a monoclonal antibody that binds to C5 to prevent formation of the membrane attack complex ,is a safe and effective therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Membranoproliferative Glomerulonephritis

Interventions

EculizumabDRUG

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy-proven primary MPGN * Creatinine clearance \>20 ml/min per 1.73m2 * 24-hour proteinuria persistently exceeding 3,5g in adults or exceeding 40mg/h/m2 in children (or exceeding 2mg protein/mg creatinine in children spot urine samples) * Persistently low C3 levels in at least two consecutive evaluations * Persistently high sC5b9 levels (\>1000 ng/ml) in at least two previous consecutive evaluations * Written informed consent (by parents or tutors if underage) Exclusion Criteria: * Age ≥75 years * Secondary MPGN (evidence of infection, immunological disease including vasculitis, systemic diseases and proliferative disorders) * Evidence at kidney biopsy evaluation of severe chronic histological changes that very unlikely could benefit of eculizumab therapy * Concomitant steroid or immunosuppressive therapy for immuno-mediated disease * Pregnancy or lactating * Childbearing potential without effective contraception * Any clinically relevant condition that might affect completion of the study participation and/or confound study results * Inability to understand the potential risks and benefits of the study * Legal incapacity

Locations (13)

Ospedale Pediatrico "Giovanni XXIII" - U:O Nefrologia

Bari, BA, Italy

A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/IRCCS IRFMN - Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò

Bergamo, BG, Italy

Policlinico Sant'Orsola -Malpighi - U.O.S. Nefrologia e dialisi pediatrica

Outcomes

Primary Outcomes

24hours proteinuria

Time frame: Changes from baseline at week 1,12,24,36,48 and 72.

Secondary Outcomes

Terminal complement complex (sC5b-9) levels

Time frame: Changes from baseline at 1,2, 3, 4,12,24,36,48,52,56,60 and 72 week.

Glomerular filtration rate (GFR) measured by iohexol plasma clearance and estimated.

Time frame: Changes from Baseline at 1,24, 48 and 72 week.

Time to disease progression.

Time frame: Up 72 week.

Data from ClinicalTrials.gov

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