Eculizumab in Primary MPGN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.

NCT04662723

Glomerulonephritis Immunoglobulin A Nephropathy

RECRUITING PHASE4

An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

NCT05809531

C3G IC-MPGN C3 Glomerulopathy +9 more

ACTIVE_NOT_RECRUITING PHASE3

MOR202 for Refractory MN

NCT04893096

Membranous Nephropathy

COMPLETED PHASE2

Complement C5 mAb in the Treatment of Anti-GBM Disease

NCT06513338

Autoimmune Diseases

COMPLETED PHASE2

Eculizumab Use in the Postpartum Period for the Treatment of Pregnancy Associated aHUS: A Case Series

NCT03574506

Atypical Hemolytic Uremic Syndrome Pregnancy

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Membranoproliferative Glomerulonephritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Eculizumab

Patient Body weight ≥40 kg: initial phase 900 mg weekly x 4 and maintenance phase 1200 mg at week 5; then 1200 mg every 2 weeks Patient Body weight 30 - \<40 kg : initial phase 600 mg weekly x 2 and maintenance phase 900 mg at week 3; then 900 mg every 2 weeks

Group Type EXPERIMENTAL

Eculizumab

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eculizumab

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Soliris

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No