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Completed

NCT Number: NCT02093533

Eculizumab in Primary MPGN

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.

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Key information

Conditions

Membranoproliferative Glomerulonephritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranoproliferative Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Nephrosis Nephrotic Syndrome Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale Pediatrico "Giovanni XXIII" - U:O Nefrologia, Bari, BA, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eculizumab

Drug

Other names: Soliris

Primary outcomes

  1. 24hours proteinuria

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

Secondary outcomes

  1. 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.

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

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

  3. Time to disease progression.

    Time frame: Up 72 week.

Other outcomes

  1. Number of participants with Adverse Events as a measure of safety.

    Time frame: Participants will be followed for the duration of the study, an expected average of 72 weeks

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Collaborators

  • Alexion Pharma Italy s.r.l.

Registry information

Official study title

EVALUATING THE MORPHOFUNCTIONAL EFFECTS OF ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS: A PILOT, SINGLE ARM STUDY IN TEN PATIENTS WITH PERSISTENT HEAVY PROTEINURIA

Acronym: EAGLE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2014
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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