Membranoproliferative GlomerulonephritisPhase 2EAGLENCT02093533
Eculizumab in Primary MPGN
A Phase 2 study testing Eculizumab in people with Membranoproliferative Glomerulonephritis, run by Mario Negri Institute for Pharmacological Research at 13 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Membranoproliferative Glomerulonephritis
- What is being tested?
- Eculizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 13 sitesItaly
- Study dates
- Mar 2014to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Ospedale Pediatrico "Giovanni XXIII" - U:O Nefrologia
Bari, BA
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
Policlinico Sant'Orsola -Malpighi - U.O.S. Nefrologia e dialisi pediatrica
Bologna, BO
Ospedale Centrale
Bolzano, 39100
Policlinico "G.Martino" - U.O. Nefrologia e Dialisi
Messina, ME
Policlinico "Federico II" - U.O. Nefrologia
Naples
Policlinico Universitario di Padova - U.O. Nefrologia Pediatrica
Padova, PD
Ospedale degli Infermi - U.O. Nefrologia e Dialisi
Rimini
C.I. Columbus-Università Cattolica del S.Cuore - UOC Nefrologia e Dialisi
Roma
Ospedale Pediatrico "Bambin Gesù" - U.O. Nefrologia
Roma
Presidio Ospedaliero O.I.R.M. "Sant'Anna" - U.O. Nefrologia
Torino
Ospedale "Santa Chiara" - U.O. Nefrologia
Trento
Ospedale Cà Foncello - U.O. Nefrologia
Treviso
About this study
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
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.
- Conditions
- Membranoproliferative Glomerulonephritis
- Being tested
- Eculizumab
- Keywords
- Membranoproliferative glomerulonephritis, Nephrotic syndrome, Proteinuria, Alternative complement pathway, Complement inhibition, Eculizumab
- Medical subject headings
- Glomerulonephritis, Membranoproliferative, Nephrotic Syndrome, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EculizumabDrug
Also called Soliris
| Study group | Role | What they receive |
|---|---|---|
| Eculizumab | Experimental | 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 Receives: Drug: Eculizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
24hours proteinuria
Measured: Changes from baseline at week 1,12,24,36,48 and 72.
Secondary outcomes (3)
Terminal complement complex (sC5b-9) levels
Measured: 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.
Measured: Changes from Baseline at 1,24, 48 and 72 week.
Time to disease progression.
Measured: Up 72 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Membranoproliferative GlomerulonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Collaborators
- Alexion Pharma Italy s.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093533
- Sponsor's protocol ID
- EAGLE
- Other IDs
- 2013-003826-10
- Acronym
- EAGLE
- Status last verified
- Jan 2018
- First submitted
- 17 Mar 2014
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02093533
- Acronym / sponsor ID
- EAGLE / EAGLE
- Conditions
- Membranoproliferative Glomerulonephritis
- Keywords
- Membranoproliferative glomerulonephritis, Nephrotic syndrome, Proteinuria, Alternative complement pathway, Complement inhibition, Eculizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Alexion Pharma Italy s.r.l.
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eculizumab | Experimental | Drug: EculizumabPatient 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 |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EculizumabAlso: Soliris | Drug | Eculizumab |
Primary outcome
24hours proteinuria
Time frame: Changes from baseline at week 1,12,24,36,48 and 72.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
Related trials for Membranoproliferative Glomerulonephritis
Not yet recruitingObservational study
Pilot STUDY to Monitor Ex-vivo the Biological Effects of the C3 Inhibitor, PEGCETACOPLAN, on Activation of Complement in Fluid Phase and on Podocytes in Patients With C3G and Primary IC-MPGN
Glomerulopathy, C3G
Not yet recruitingPhase 3
To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative
RecruitingObservational study
A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain
Complement 3 Glomerulopathy
RecruitingPhase 4
Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study
C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Active, not recruitingPhase 2
A Study of SGB-9768 in Patients With Complement-mediated Kidney Diseases
IgA Nephropathy (IgAN), C3 Glomerulopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eculizumab in people with Membranoproliferative Glomerulonephritis, run by Mario Negri Institute for Pharmacological Research at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24hours proteinuria (time frame: Changes from baseline at week 1,12,24,36,48 and 72.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.