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Eculizumab in Primary MPGN (EAGLE)
This study is ongoing, but not recruiting participants.
Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborator:
Alexion Pharma Italy s.r.l.
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT02093533
First received: March 17, 2014
Last updated: May 29, 2017
Last verified: May 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Membranoproliferative Glomerulonephritis | Drug: Eculizumab | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking 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 |
Resource links provided by NLM:
Drug Information available for:
Eculizumab
Genetic and Rare Diseases Information Center resources:
Glomerulonephritis
Membranoproliferative Glomerulonephritis
U.S. FDA Resources
Further study details as provided by Mario Negri Institute for Pharmacological Research:
Primary Outcome Measures:
- 24hours proteinuria [ Time Frame: Changes from baseline at week 1,12,24,36,48 and 72. ]
Secondary Outcome Measures:
- 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. ]
Other Outcome Measures:
- 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 ]
| Estimated Enrollment: | 10 |
| Actual Study Start Date: | March 2014 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02093533
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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 ) |
| Study First Received: | March 17, 2014 |
| Last Updated: | May 29, 2017 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017