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

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
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Drug: Eculizumab
Other Name: Soliris
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- 24hours proteinuria [ Time Frame: Changes from baseline at week 1,12,24,36,48 and 72. ]
- 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. ]
- 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 ]

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

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
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 |
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 |