Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

PHASE3CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

November 12, 2021

Primary Completion Date

June 26, 2024

Study Completion Date

January 14, 2025

Conditions
C3GIC-MPGNC3 GlomerulopathyC3 GlomerulonephritisComplement 3 GlomerulopathyComplement 3 Glomerulopathy (C3G)Complement 3 GlomerulonephritisDense Deposit DiseaseDDDMembranoproliferative GlomerulonephritisMembranoproliferative Glomerulonephritis (MPGN)Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Interventions
DRUG

Pegcetacoplan

Complement (C3) Inhibitor

OTHER

Placebo

Sterile solution of equal volume to active arm

Trial Locations (125)

1070

Hopital Erasme HUB Service Pharmacie, Brussels

1629

Hospital Universitario Austral, Buenos Aires

2605

Canberra Hospital - Renal Clinical Trials & Research Unit, Garran

2650

University Hospital Antwerp (32004), Edegem

3080

Seoul National University Hospital (82005), Seoul

6020

Medical University Hospital Innsbruck (43004), Innsbruck

10032

CUIMC - Columbia Nephrology, New York

10117

Charite Universitatsmedizin (49007), Berlin

11040

Cohen Children Hospital, New Hyde Park

16147

IRCCS Istituto Giannina Gaslini (39012), Genova

18017

Northeast Clinical Research Center, LLC, Bethlehem

20156

Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

27100

Instituti Clinici Scientifici Maugeri SPA-IRCCS, Pavia

28041

Hospital Universitario 12 de Octubre, Nephrology Department, Madrid

30322

Emory University School of Medicine, Atlanta

30342

Fides Clinical Research, LLC (01042), Atlanta

30625

Medizinische Hochschule Hannover, Studienzentrum fur Nieren und Hochdruckerkrankungen, Hanover

31059

Rangueil Hospital-University Hospital Center (CHU) of Toulouse, Toulouse

32610

University of Florida, Gainesville

33076

CHU de Bordeaux - Hopital Pellegrin, Bordeaux

34295

CHU Montpellier, Hopital Lapeyronie, Montpellier

35128

Azienda Ospedaliera Universitaria di Padova (39011), Padua

35294

University of Alabama at Birmingham, Birmingham

39008

Hospital Universitario Marques de Valdecilla, Santander

40138

Policlinico Sant Orsola-Malpighi, Bologna

41013

University Hospital of Virgen del Rocio, Seville

42055

CHU de Saint Etienne, Hospital Nord, Saint-Priest-en-Jarez

42601

Keimyung University Dongsan Medical Center, Daegu

43210

The Ohio State University Medical Center, Columbus

44093

Nantes University Hospital, Nantes

46017

Hospital Universitario Dr Peset, Valencia

46804

Nephrology Associates of Northern IL and Inn (01043), Fort Wayne

48109

University of Michigan Medical Center, Ann Arbor

48149

Universitatsklinikum Munster, Münster

52242

The University of Iowa, Iowa City

55131

Universitatsmedizin Mainz, Mainz

59037

Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology, Paris

60523

NANIU Research Chicago (01040), Oak Brook

60611

Institute for Public Health and Medicine Northwestern University Northwestern University (01041), Chicago

64102

Children's Mercy Hospital, Kansas City

67091

University Hospital Strasbourg, Strasbourg

69437

Hospital Edouard Herriot, Hospices Civils de Lyon, Lyon

70123

Policlinico di Bari, Bari

75015

Hopital Necker (33014), Paris

Hôpital Européen Georges-Pompidou, Paris

77030

Texas Children's Hospital, Houston

79902

MedResearch Inc, El Paso

80045

Children's Hospital Colorado, Aurora

90022

Academic Medical Research Institute, Los Angeles

90033

Keck School of Medicine, University of Southern California, Los Angeles

90095

Ronald Reagan UCLA Medical Center (01035), Los Angeles

92868

UCI Center for Clinical Research, Orange

93053

University Hospital Regensburg (49004), Regensburg

94010

Hopital Henri-Mondor, Créteil

95817

UC Davis Medical Center (Transplant Research) (01016), Sacramento

97239

Oregon Health & Science University (01038), Portland

98125

Universita degli Studi di Messina, Messina

3109601

Rambam Health Care Campus, Haifa

4920235

Institute of Pediatric Nephrology, Petah Tikva

9208650

NHO Kanazawa Medical Center, Kanazawa

02115

Boston Children's Hospital (01013), Boston

01107

Renal and Transplant Associates of New England, PC, Springfield

07601

Hackensack Meridian Health, Hackensack

CPA X5016KEH

Hospital Privado-Universitario de Cordoba, Córdoba

X5000

Clinica Privada Velez Sarsfield, Córdoba

QLD 4102

Princess Alexandra Hospital, Woolloongabba

Princess Alexandra Hospital, Woolloongabba

VIC 3128

Monash University, Box Hill

VIC 3065

St. Vincents Melbourne, Fitzroy

A-1090

Medizinische Universität Wien, Vienna

B-3000

Catholic University of Leuven, Leuven

B-4000

CHU Sart-Tilman, Liège

Clinical Trials CHU de Liège, Liège

30150-221

Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte

36025-340

Centro de Tratamento de Doencas Renais, Juiz de Fora

90020-090

Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

18618-687

HC UNESP Botucatu, Botucatu

60430-372

Hospital Universitario Walter Cantidio, Fortaleza

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

52010-095

Real Hospital Portuguas de Beneficancia em Pernambuco, Recife

14110-000

Hospital das Clinicas de Ribeirao Preto, Division of Nephrology, Ribeirão Preto

22211-225

Nefrologia I-Dor, Rio de Janeiro

22270-060

Ruschel Medicina E Pesquisa Clinica, Rio de Janeiro

150900-000

Hospital de Base, São José do Rio Preto

04038-002

UNIFESP - Hospital Sao Paulo, São Paulo

05403-000

Instituto da Crianca-Hospital das Clinicas University of Sao Paulo, São Paulo

05403-900

HCFMUSP-Hospital Clinicas da Faculdade Medicina da Universidade de São Paulo, São Paulo

M5G 1X8

Hospital for Sick Children (11003), Toronto

QC H1T2M4

Hopital Maisonneuve-Rosemont, Montreal

140 21

Institute for Clinical and Experimental Medicine, Prague

Unknown

Faculty Hospital Kralovske Vinohrady (42002), Prague

D-45147

Universitatsklinikum Essen (AoR), Zentrum fur Kinder (49005), Essen

00165

Ospedale Pediatrico Bambino Gesu, Rome

466-8560

Nagoya University Hospital (81003), Nagoya

474-8710

Aichi Children's Health and Medical Center, Ōbu

371-8511

Gunma University Hospital (81006), Maebashi

852-8501

Nagasaki University Hospital (81005), Nagasaki

430-8558

Seirei Hamamatsu General Hospital (81004), Hamamatsu

530-8480

Kitano Hospital, Osaka

181-8611

Kyorin University Hospital (81009), Tokyo

1105 AZ

Emma Kinderziekenhuis, Amsterdam UMC, Amsterdam

9713 GZ

University Medical Center Groningen, Groningen

6500 HB

Radboud University Medical Center, Nijmegen

90-153

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Lodz

92-213

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Lodz

03722

Yonsei University College of Medicine, Sinchon Severance Hospital, Seoul

03080

Seoul National University Hospital, Soeul

08025

Fundació Puigvert, Barcelona

08035

Hospital Universitari Vall D'Hebron, Barcelona

Hospital Universitario Materno-Infantil Vall d' Hebron, Nefrologia Pediatrica, Barcelona

08950

Hospital Materno Infantil Sant Joan de Deu, Barcelona

CH-3010

Inselspital, Bern University Hospital, Bern

CH-1011

CHUV Lausanne, Lausanne

CH-8091

Universitatsspital Zurich, Zurich

GL1 3NN

Gloucestershire Hospitals NHS Foundation Trust, Gloucester

LE1 5WW

University Hospitals of Leicester NHS trust (44003), Leicester

NW3 2QG

Royal Free London NHS Foundation Trust (44015), London

SE1 7EH

Evelina London Children Hospital (44016), London

SW17 0QT

St George'Äôs University Hospitals NHS Foundation Trust (44014), London

W12 0HS

Imperial College Healthcare NHS Trust, London

WC1N 3JH

Great Ormond Street Hospital Foundation Trust, London

M13 9WL

Royal Manchester Children's Hospital, Manchester

NG7 2UH

Nottingham Children's Hospital, Nottingham

Sponsors
All Listed Sponsors
lead

Apellis Pharmaceuticals, Inc.

INDUSTRY