European Union · Phase II and III, including IIIb · C3 glomerulopathy
EU Phase II and III C3 glomerulopathy trials: sites, PIs and sample sizes
Mario Negri Institute in Ranica and Radboud University Medical Center each appear in five of seven studies involving patients with C3 glomerulopathy (C3G). Across the seven studies, 68 EU sites and 76 named investigators span 13 countries, with separate networks for Phase II development, pivotal trials and long-term follow-up.
three Phase II, four Phase III/IIIb
across 13 countries
across all seven studies
Top 10 sites · All seven studies
Four centres span both pivotal trials and their extensions
Mario Negri, Radboud, Bambino Gesù and Milan Policlinico all appear in VALIANT, APPEAR-C3G and both extension studies. Mario Negri and Radboud also participate in NOBLE’s post-transplant study.
Differences by phase and patient population
Phase IIThree distinct networksThe three studies list 19 sites with no site shared between them. NOBLE lists three centres, OMS906-C3G-001 three, and the Swedish Reninblock-C3G study 13.
C3G onlyAPPEAR-C3G and Reninblock-C3GThe two studies together list 33 sites, with no shared site. The other five studies also admit IC-MPGN or idiopathic ICGN, so their site experience covers mixed populations.
ExtensionsTwo returning-patient studiesThe extensions list 45 sites, six shared between them. Their additional appearances represent follow-up experience, rather than independent newly recruited patient populations.
Site counts group departments and naming variants at the same centre. Separately identifiable hospital campuses remain distinct. Counts include historical and currently listed participation, not recruitment performance or open-site availability.
Top 10 principal investigators · All seven studies
Giuseppe Remuzzi appears in five studies, Marina Vivarelli in four
Four investigators follow with three study appearances each. Shared institutions can involve different adult, paediatric or transplant investigators.
Differences by phase and patient population
Pivotal Phase IIIVALIANT and APPEAR-C3GGiuseppe Remuzzi and Marina Vivarelli appear in both. At Milan Policlinico, VALIANT names Giovanni Montini while APPEAR-C3G names Gianluigi Ardissino.
Post-transplantNOBLE · Phase IIThe three named investigators are Gere Sunder-Plassmann, Raphaël Duivenvoorden and Giuseppe Remuzzi. NOBLE specifically studies recurrent disease in kidney transplants.
C3G onlyAdult and paediatric settingsAPPEAR-C3G names 20 investigators and Reninblock-C3G names 17, with no investigator shared between the two studies. Their patient age ranges and treatment settings differ.
Top 10 of 13 EU countries
Italy and the Netherlands each appear in five studies
Germany follows with four. Italy, the Netherlands and Germany are the only countries appearing in both pivotal Phase III trials and both extensions.
Poland, Slovakia and Sweden also appear in one study each. Countries tied on study count are ordered alphabetically. A multinational study can appear in several countries.
Differences by phase and patient population
Phase IISix EU countriesNOBLE lists Austria, Italy and the Netherlands. OMS906-C3G-001 lists Lithuania and Poland. Reninblock-C3G is confined to Sweden in the EU records.
C3G onlyEight-country networkAPPEAR-C3G lists France, Germany, Greece, Italy, the Netherlands, Slovakia and Spain. Reninblock-C3G adds Sweden, with 13 listed centres.
ExtensionsNine EU countriesThe two extensions share Czechia, France, Germany, Italy, the Netherlands and Spain. The iptacopan extension additionally lists Greece, while VALE additionally lists Austria and Belgium.
Worldwide participants · Actual and estimated enrollment
VALIANT enrolled 124 participants, while the largest extension targets 225
NOBLE enrolled 13 participants. The other five figures are registry estimates, including 98 for APPEAR-C3G and 100 for VALE.
Blue bars: actual enrollment. Green bars: estimated enrollment. Mixed-disease totals include patients with conditions other than C3G.
Differences by phase and patient population
C3G onlyPhase III and Phase IIAPPEAR-C3G lists an estimate of 98, including its adolescent cohort. Reninblock-C3G plans 30 children and adults.
Mixed populationsC3G and related glomerular diseaseVALIANT’s 124 actual participants and NOBLE’s 13 include C3G or IC-MPGN. OMS906-C3G-001 plans 20 participants with C3G or idiopathic ICGN. These are not C3G-only counts.
ExtensionsReturning participantsThe iptacopan extension estimates 225 across eligible parent studies and VALE estimates 100 VALIANT completers. Participants can occur in both a parent trial and its extension, so study totals must not be added as unique patients.
Enrollment figures use each linked ClinicalTrials.gov record’s latest posted value as retrieved on 17 September 2026. An estimated figure is a target, not confirmed enrollment. Country and site rankings use the listed EU trial locations.
The seven EU Phase II and III C3G studies
Five are parent or standalone studies, and two continue treatment after a parent study. IC-MPGN means immune-complex membranoproliferative glomerulonephritis. ICGN means immune complex-mediated glomerulonephritis.
| Study / EU CT number | Phase | Treatment and patient population | EU sites |
|---|---|---|---|
| VALIANT 2024-514130-20-00 | III | Pegcetacoplan, randomized placebo-controlled. C3G or IC-MPGN, native kidneys or post-transplant recurrence. | 12 |
| APPEAR-C3G 2023-509331-83-00 | III | Iptacopan, randomized placebo-controlled. C3G, adult and adolescent cohorts. | 20 |
| Iptacopan extension 2023-509343-27-00 | IIIb | Open-label follow-up after parent studies. C3G or idiopathic IC-MPGN. | 33 |
| VALE 2023-504625-39-00 | III | Pegcetacoplan extension for VALIANT completers with clinical benefit. C3G or IC-MPGN. | 18 |
| NOBLE 2024-511544-36-00 | II | Pegcetacoplan, randomized open-label. Adults with post-transplant recurrence of C3G or IC-MPGN. | 3 |
| OMS906-C3G-001 2023-508669-33-00 | II | OMS906, open-label proof of concept. Adults with C3G, including dense deposit disease, or idiopathic ICGN. | 3 |
| Reninblock-C3G 2024-515892-36-00 | II | Aliskiren versus enalapril, randomized crossover. C3G in children aged ≥6 years and adults. | 13 |
The iptacopan extension is described as Phase IIIb in CTIS, with an integrated III/IV phase code, and as Phase III in ClinicalTrials.gov. It is included in the Phase III group. Study listings do not establish that a site is currently recruiting.
Sources: CTIS trial records and protocols and the seven ClinicalTrials.gov records linked above, reviewed 17 September 2026. Rankings count distinct study protocols, including extensions. The charts show up to ten entries, with alphabetical ordering for ties. Site and investigator appearances describe the whole study, not confirmed C3G enrollment at each site.