Trials Sponsors Conditions Drugs Pricing

Conditions

Glomerulopathy C3G Membranoproliferative Glomerulonephritis (MPGN)

Keywords

Immune complex-associated MPGNC3 GlomerulopathyComplement activationPodocytesPegcetacoplanKidney function

Outcome Measures

Primary Outcomes (1)

Biomarkers of complement activation
Calculation of C3, C4d and C5b-9 deposits (C3D, C4dD, C5b-9D) expressed in pixels²
At baseline, day 14, day 28, month 3 and every 3 months until end of study

Study Arms (2)

Patients

Adult and adolescent patients with C3G or primary IC-MPGN receiving pegcetacoplan therapy under real-world conditions.

Procedure: Blood sample

Healthy volunteers

Samples will be selected from among those collected and stored in the certified biobank (UNI EN ISO 9001:2015; certification n° 6121) of "Centro Daccò" (Centro di Risorse Biologiche Mario Negri - Biobanca Malattie Rare e Renali) from participants of other MPGN studies.

Procedure: Blood sample

Interventions

Blood sampleProcedure

From each patient, 10 ml of blood will be collected without anticoagulant

Healthy volunteersPatients

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients: adult or adolescent patients with a diagnosis of C3G or primary IC-MPGN in native kidneys, or with recurrent disease in the kidney graft, will be enrolled. Patients will be recruited among those receiving pegcetacoplan therapy for C3G or primary IC-MPGN under real-world conditions. Healthy volunteers: selected from among those collected and stored in the certified biobank (UNI EN ISO 9001:2015; certification n° 6121) of "Centro Daccò" (Centro di Risorse Biologiche Mario Negri - Biobanca Malattie Rare e Renali) for the MPGN studies. The number of samples will be limited to the minimum number required to obtain an adequate reference dataset, up to a maximum of 10 healthy controls. NHS will be tested in parallel with patient and healthy control sera as a reference.

You may qualify if:

Sponsors & Collaborators

Mario Negri Institute for Pharmacological Research
Otherlead

Study Sites (1)

Clinical Research Centre for Rare Diseases Aldo e Cele Daccò

Ranica, BG, 24020, Italy

Marina Noris, PhDCONTACT+39 035 4535 362 marina.noris@marionegri.it

MeSH Terms

Conditions

Glomerulonephritis, Membranoproliferative

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling

Study Officials

Giuseppe Remuzzi, M.D.
Istituto Di Ricerche Farmacologiche Mario Negri
STUDY DIRECTOR

Central Study Contacts

Marina Noris, PhD

CONTACT

+39 035 4535 362 marina.noris@marionegri.it

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 23, 2026

First Posted

October 29, 2026

Study Start

March 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

February 2030

Estimated

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Patients

Healthy volunteers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Patients

Healthy volunteers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations