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Eculizumab in Primary MPGN (EAGLE)

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ClinicalTrials.gov Identifier: NCT02093533
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Alexion Pharma Italy s.r.l.
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Membranoproliferative Glomerulonephritis Drug: Eculizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EVALUATING THE MORPHOFUNCTIONAL EFFECTS OF ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS: A PILOT, SINGLE ARM STUDY IN TEN PATIENTS WITH PERSISTENT HEAVY PROTEINURIA
Actual Study Start Date : March 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: Eculizumab
Other Name: Soliris


Outcome Measures
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Primary Outcome Measures :
  1. 24hours proteinuria [ Time Frame: Changes from baseline at week 1,12,24,36,48 and 72. ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093533


Locations
Italy
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
Bologna, BO, Italy
Policlinico "G.Martino" - U.O. Nefrologia e Dialisi
Messina, ME, Italy
Policlinico Universitario di Padova - U.O. Nefrologia Pediatrica
Padova, PD, Italy
Ospedale Centrale
Bolzano, Italy, 39100
Policlinico "Federico II" - U.O. Nefrologia
Napoli, Italy
Ospedale degli Infermi - U.O. Nefrologia e Dialisi
Rimini, Italy
C.I. Columbus-Università Cattolica del S.Cuore - UOC Nefrologia e Dialisi
Roma, Italy
Ospedale Pediatrico "Bambin Gesù" - U.O. Nefrologia
Roma, Italy
Presidio Ospedaliero O.I.R.M. "Sant'Anna" - U.O. Nefrologia
Torino, Italy
Ospedale "Santa Chiara" - U.O. Nefrologia
Trento, Italy
Ospedale Cà Foncello - U.O. Nefrologia
Treviso, Italy
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Alexion Pharma Italy s.r.l.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT02093533     History of Changes
Other Study ID Numbers: EAGLE
2013-003826-10 ( EudraCT Number )
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by Mario Negri Institute for Pharmacological Research:
Membranoproliferative glomerulonephritis
Nephrotic syndrome
Proteinuria
 Alternative complement pathway
Complement inhibition
Eculizumab

Additional relevant MeSH terms:
Glomerulonephritis
Glomerulonephritis, Membranoproliferative
Nephritis
 Kidney Diseases
Urologic Diseases
Immune System Diseases