Back to resultsPhase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis (VALIANT)
Primary Purpose
C3G, IC-MPGN, C3 Glomerulopathy
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pegcetacoplan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for C3G
Eligibility Criteria
Inclusion Criteria:
- Aged at least 18 years; where approved, adolescents (aged 12-17 years) weighing at least 30 kg may also be enrolled.
- A diagnosis of primary C3G or IC-MPGN (with or without previous renal transplant).
Evidence of active renal disease, based on one or more of the following:
- In adults or adolescents with a baseline renal biopsy, at least 2+ staining for C3c on the baseline renal biopsy collected during screening, per the central pathology laboratory.
- In adolescents not providing a baseline renal biopsy, at least one of the following:
- Serum C5b-9 level above the upper limit of normal (ULN) during screening.
- Serum C3 below the LLN during screening.
- Presence of an active urine sediment during screening, as evidenced by hematuria with at least 5 red blood cells (RBCs) per high-power field (HPF) and/or red blood cell casts on local or central microscopic analysis of urine.
- Presence of C3 nephritic factor within 6 months of screening, based on central lab results or medical history.
- No more than 50% global glomerulosclerosis or interstitial fibrosis on the baseline biopsy, for adult subjects or adolescent subjects providing a baseline biopsy.
- At least 1 g/day of proteinuria on a screening 24-hour urine collection, and a uPCR of at least 1000 mg/g on at least 2 first-morning urine samples collected during screening.
- eGFR ≥30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease-Epidemiology Collaboration creatinine equation for adults, or the Bedside Schwartz equation for adolescents.
Stable regimen for C3G/IC-MPGN treatment, as described below:
- Stable and optimized angiotensin converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) therapy for at least 12 weeks prior to randomization, in the opinion of the investigator.
- Stable doses of other medications that can affect proteinuria (eg, steroids, mycophenolate mofetil (MMF) and/or other allowed immunosuppressants that the patient is receiving for treatment of C3G) for at least 8 weeks prior to the baseline renal biopsy, and at least 12 weeks prior to randomization.
- Have received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) within 5 years prior to randomization or agree to receive vaccinations during screening.
Exclusion Criteria:
- Previous exposure to pegcetacoplan.
- C3G/IC-MPGN secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, a systemic autoimmune disease such as systemic lupus erythematosus, chronic antibody-mediated rejection, or a medication), in the opinion of the investigator.
- Current or prior diagnosis of human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) infection or positive serology during screening that is indicative of infection with any of these viruses.
- Weight more than 100 kg at screening.
- Hypersensitivity to pegcetacoplan or to any of the excipients.
- History of meningococcal disease.
Malignancy, except for the following:
- Cured basal or squamous cell skin cancer
- Curatively treated in situ disease
- Malignancy-free and off treatment for ≥5 years
- An absolute neutrophil count <1000 cells/mm3 at screening.
- Use of rituximab, belimumab, or any approved or investigational anticomplement therapy other than pegcetacoplan within 5 half-lives of that product prior to the screening period.
- Female subjects who are pregnant or who are currently breastfeeding and are unwilling to discontinue for the duration of the study and for at least 90 days after the final dose of study drug.
- Presence or suspicion of severe recurrent or chronic infections that, in the opinion of the investigator, may place the subject at unacceptable risk by study participation.
Sites / Locations
- University of Alabama at BirminghamRecruiting
- Academic Medical Research InstituteRecruiting
- Keck School of Medicine, University of Southern CaliforniaRecruiting
- UCI Center for Clinical ResearchRecruiting
- Children's Hospital ColoradoRecruiting
- University of FloridaRecruiting
- Emory University School of MedicineRecruiting
- The University of IowaRecruiting
- Renal and Transplant Associates of New England, PC
- University of Michigan Medical CenterRecruiting
- Children's Mercy HospitalRecruiting
- Hackensack Meridian HealthRecruiting
- Cohen Children HospitalRecruiting
- CUIMC - Columbia NephrologyRecruiting
- The Ohio State University Medical CenterRecruiting
- Northeast Clinical Research Center, LLCRecruiting
- MedResearch IncRecruiting
- Texas Children's HospitalRecruiting
- Hospital Universitario AustralRecruiting
- Hospital Privado-Universitario de CordobaRecruiting
- Clinica Privada Velez SarsfieldRecruiting
- Canberra Hospital - Renal Clinical Trials & Research UnitRecruiting
- Princess Alexandra HospitalRecruiting
- Monash UniversityRecruiting
- St. Vincents MelbourneRecruiting
- Princess Alexandra HospitalRecruiting
- Medizinische Universität WienRecruiting
- Hopital Erasme HUB Service PharmacieRecruiting
- Catholic University of LeuvenRecruiting
- CHU Sart-TilmanRecruiting
- Clinical Trials CHU de LiègeRecruiting
- Santa Casa de Misericordia de Belo HorizonteRecruiting
- Centro de Tratamento de Doencas RenaisRecruiting
- Irmandade da Santa Casa de Misericordia de Porto AlegreRecruiting
- HC UNESP BotucatuRecruiting
- Hospital Universitario Walter CantidioRecruiting
- Irmandade da Santa Casa de Misericordia de Porto AlegreRecruiting
- Hospital de Clinicas de Porto AlegreRecruiting
- Real Hospital Portuguas de Beneficancia em PernambucoRecruiting
- Hospital das Clinicas de Ribeirao Preto, Division of NephrologyRecruiting
- Nefrologia I-DorRecruiting
- Ruschel Medicina E Pesquisa ClinicaRecruiting
- Hospital de BaseRecruiting
- UNIFESP - Hospital Sao PauloRecruiting
- Instituto da Crianca-Hospital das Clinicas University of Sao PauloRecruiting
- HCFMUSP-Hospital Clinicas da Faculdade Medicina da Universidade de São PauloRecruiting
- Hopital Maisonneuve-RosemontRecruiting
- Institute for Clinical and Experimental MedicineRecruiting
- CHU de Bordeaux - Hopital PellegrinRecruiting
- Hopital Henri-MondorRecruiting
- Hospital Edouard Herriot, Hospices Civils de LyonRecruiting
- CHU Montpellier, Hopital LapeyronieRecruiting
- Nantes University HospitalRecruiting
- Lille Regional University Hospital Center, Claude Huriez Hospital, Department of NephrologyRecruiting
- Hôpital Européen Georges-PompidouRecruiting
- CHU de Saint Etienne, Hospital NordRecruiting
- University Hospital StrasbourgRecruiting
- Rangueil Hospital-University Hospital Center (CHU) of ToulouseRecruiting
- Medizinische Hochschule Hannover, Studienzentrum fur Nieren und HochdruckerkrankungenRecruiting
- Universitatsmedizin MainzRecruiting
- Universitatsklinikum MunsterRecruiting
- Rambam Health Care CampusRecruiting
- Institute of Pediatric NephrologyRecruiting
- Policlinico di BariRecruiting
- Policlinico Sant Orsola-MalpighiRecruiting
- Universita degli Studi di MessinaRecruiting
- Istituto di Ricerche Farmacologiche Mario Negri IRCCSRecruiting
- ASST Grande Ospedale Metropolitano NiguardaRecruiting
- Instituti Clinici Scientifici Maugeri SPA-IRCCSRecruiting
- Ospedale Pediatrico Bambino GesuRecruiting
- Aichi Children's Health and Medical CenterRecruiting
- NHO Kanazawa Medical CenterRecruiting
- Kitano HospitalRecruiting
- Keimyung University Dongsan Medical CenterRecruiting
- Yonsei University College of Medicine, Sinchon Severance HospitalRecruiting
- Seoul National University HospitalRecruiting
- Emma Kinderziekenhuis, Amsterdam UMCRecruiting
- University Medical Center GroningenRecruiting
- Radboud University Medical CenterRecruiting
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w LodziRecruiting
- SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w LodziRecruiting
- Fundació PuigvertRecruiting
- Hospital Universitari Vall D'HebronRecruiting
- Hospital Universitario Materno-Infantil Vall d' Hebron, Nefrologia PediatricaRecruiting
- Hospital Materno Infantil Sant Joan de DeuRecruiting
- Hospital Universitario 12 de Octubre, Nephrology DepartmentRecruiting
- Hospital Universitario Marques de ValdecillaRecruiting
- University Hospital of Virgen del RocioRecruiting
- Hospital Universitario Dr PesetRecruiting
- Inselspital, Bern University HospitalRecruiting
- CHUV LausanneRecruiting
- Universitatsspital ZurichRecruiting
- Gloucestershire Hospitals NHS Foundation TrustRecruiting
- Imperial College Healthcare NHS TrustRecruiting
- Great Ormond Street Hospital Foundation TrustRecruiting
- Royal Manchester Children's HospitalRecruiting
- Nottingham Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1: Pegcetacoplan administration
Group 2: Placebo administration
Arm Description
Subcutaneous infusion of 20mL (1080 mg), twice weekly (for adults or adolescents >50kg), and the three other weight-based doses either of 10mL (540mg), 12mL (648mg), or 15mL (810mg)
Subcutaneous infusion of either 10mL, 12mL, 15mL, or 20mL, twice weekly
Outcomes
Primary Outcome Measures
The log-transformed ratio of uPCR at week 26 compared to baseline
Secondary Outcome Measures
The proportion of participants who meet the criteria for achieving a composite renal endpoint (a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and a ≥50% reduction in uPCR compared to the baseline visit.)
The proportion of participants with a reduction of at least 50% from baseline in uPCRF
Change from baseline in eGFR
For participants with evaluable renal biopsies, the change from baseline in the activity score of the C3G histologic index score
The proportion of participants with evaluable renal biopsies showing decreases in C3c staining on renal biopsy from baseline
Full Information
NCT ID
NCT05067127
First Posted
September 23, 2021
Last Updated
August 10, 2023
Sponsor
Apellis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05067127
Brief Title
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
Acronym
VALIANT
Official Title
A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apellis Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 3 study to assess the efficacy and safety of twice-weekly subcutaneous (SC) doses of pegcetacoplan compared to placebo in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN) on the basis of a reduction in proteinuria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G), Complement 3 Glomerulonephritis, Dense Deposit Disease, DDD, Membranoproliferative Glomerulonephritis, Membranoproliferative Glomerulonephritis (MPGN), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Pegcetacoplan administration
Arm Type
Experimental
Arm Description
Subcutaneous infusion of 20mL (1080 mg), twice weekly (for adults or adolescents >50kg), and the three other weight-based doses either of 10mL (540mg), 12mL (648mg), or 15mL (810mg)
Arm Title
Group 2: Placebo administration
Arm Type
Placebo Comparator
Arm Description
Subcutaneous infusion of either 10mL, 12mL, 15mL, or 20mL, twice weekly
Intervention Type
Drug
Intervention Name(s)
Pegcetacoplan
Intervention Description
Complement (C3) Inhibitor
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sterile solution of equal volume to active arm
Primary Outcome Measure Information:
Title
The log-transformed ratio of uPCR at week 26 compared to baseline
Time Frame
Baseline to week 26
Secondary Outcome Measure Information:
Title
The proportion of participants who meet the criteria for achieving a composite renal endpoint (a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and a ≥50% reduction in uPCR compared to the baseline visit.)
Time Frame
Baseline to week 26
Title
The proportion of participants with a reduction of at least 50% from baseline in uPCRF
Time Frame
Baseline to week 26
Title
Change from baseline in eGFR
Time Frame
Baseline to week 26
Title
For participants with evaluable renal biopsies, the change from baseline in the activity score of the C3G histologic index score
Time Frame
Baseline to week 26
Title
The proportion of participants with evaluable renal biopsies showing decreases in C3c staining on renal biopsy from baseline
Time Frame
Baseline to week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged at least 18 years; where approved, adolescents (aged 12-17 years) weighing at least 30 kg may also be enrolled.
A diagnosis of primary C3G or IC-MPGN (with or without previous renal transplant).
Evidence of active renal disease, based on one or more of the following:
In adults or adolescents with a baseline renal biopsy (either one collected during screening or a historic biopsy collected within 28 weeks prior to randomization), at least 2+ C3c staining on the baseline renal biopsy.
In adolescents not providing a baseline renal biopsy, at least one of the following:
Plasma sC5b-9 level above the upper limit of normal during screening
Serum C3 below the LLN during screening
Presence of an active urine sediment during screening, as evidenced by hematuria with at least 5 red blood cells (RBCs) per high-power field (HPF) and/or red blood cell casts on local or central microscopic analysis of urine.
Presence of C3 nephritic factor within 6 months of screening, based on central laboratory results or medical history.
No more than 50% global glomerulosclerosis or interstitial fibrosis on the baseline biopsy for adult participants or adolescent participants providing a baseline biopsy.
At least 1 g/day of proteinuria on a screening 24-hour urine collection and a uPCR of at least 1000 mg/g in at least 2 first-morning spot urine samples collected during screening.
eGFR ≥30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease-Epidemiology Collaboration creatinine equation for adults or the Bedside Schwartz equation for adolescents.
Stable regimen for C3G/IC-MPGN treatment, as described below:
Angiotensin-converting enzyme inhibitor/, angiotensin receptor blocker, and/or sodium-glucose cotransporter-2 inhibitor therapy that is stable and optimized, in the opinion of the investigator, for at least 12 weeks prior to randomization
Stable doses of other medications that can affect proteinuria (eg, steroids, mycophenolate mofetil, and/or other allowed immunosuppressants that the participant is receiving for treatment of C3G or IC-MPGN) for at least 812 weeks prior to the baseline renal biopsy and randomization.
If a participant is on prednisone (or other systemic corticosteroid) for C3G or IC-MPGN treatment, the dosage is stable and no higher than 20 mg/day (or equivalent dosage of a corticosteroid other than prednisone) for at least 12 weeks prior to randomization.
Have received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) within 5 years prior to randomization or agree to receive vaccinations during screening.
Exclusion Criteria:
Previous exposure to pegcetacoplan.
C3G/IC-MPGN secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, a systemic autoimmune disease such as systemic lupus erythematosus, chronic antibody-mediated rejection, or a medication), in the opinion of the investigator.
Current or prior diagnosis of human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) infection or positive serology during screening that is indicative of infection with any of these viruses.
Body weight greater than 100 kg at screening.
Hypersensitivity to pegcetacoplan or to any of the excipients.
History of meningococcal disease.
Malignancy, except for the following:
Cured basal or squamous cell skin cancer
Curatively treated in situ disease
Malignancy-free and off treatment for ≥5 years
Severe infection (eg, requiring IV antibiotic therapy) within 14 days prior to the first dose of pegcetacoplan.
An absolute neutrophil count <1000 cells/mm3 at screening.
Use of rituximab, belimumab, or any approved or investigational anticomplement therapy other than pegcetacoplan within 5 half-lives of that product prior to the screening period.
Female participants who are pregnant or who are currently breastfeeding and are unwilling to discontinue for the duration of the study and for at least 90 days after the final dose of study drug.
Presence or suspicion of severe infection during the screening period (including but not limited to recurrent or chronic infections) that, in the opinion of the investigator, may place the participant at unacceptable risk by study participation.
Known or suspected hereditary fructose intolerance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Apellis Clinical Trial Information Line
Phone
833-284-6361 (833-CTinfo1)
Email
clinicaltrials@apellis.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Individual Site Status
Recruiting
Facility Name
Keck School of Medicine, University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
UCI Center for Clinical Research
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Renal and Transplant Associates of New England, PC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Individual Site Status
Completed
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64102
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack Meridian Health
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Cohen Children Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Name
CUIMC - Columbia Nephrology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Individual Site Status
Recruiting
Facility Name
MedResearch Inc
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Austral
City
Buenos Aires
ZIP/Postal Code
1629
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Privado-Universitario de Cordoba
City
Córdoba
ZIP/Postal Code
CPA X5016KEH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Privada Velez Sarsfield
City
Córdoba
ZIP/Postal Code
X5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Canberra Hospital - Renal Clinical Trials & Research Unit
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
QLD 4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash University
City
Box Hill
ZIP/Postal Code
VIC 3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
St. Vincents Melbourne
City
Fitzroy
ZIP/Postal Code
VIC 3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
QLD 4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hopital Erasme HUB Service Pharmacie
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Catholic University of Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clinical Trials CHU de Liège
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Tratamento de Doencas Renais
City
Juiz De Fora
State/Province
Minas Gerais
ZIP/Postal Code
36025-340
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
HC UNESP Botucatu
City
Botucatu
ZIP/Postal Code
18618-687
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Walter Cantidio
City
Fortaleza
ZIP/Postal Code
60430-372
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Real Hospital Portuguas de Beneficancia em Pernambuco
City
Recife
ZIP/Postal Code
52010-095
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clinicas de Ribeirao Preto, Division of Nephrology
City
Ribeirão Preto
ZIP/Postal Code
14110-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Nefrologia I-Dor
City
Rio De Janeiro
ZIP/Postal Code
22211-225
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Ruschel Medicina E Pesquisa Clinica
City
Rio De Janeiro
ZIP/Postal Code
22270-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Base
City
São José Do Rio Preto
ZIP/Postal Code
150900-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
UNIFESP - Hospital Sao Paulo
City
São Paulo
ZIP/Postal Code
04038-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto da Crianca-Hospital das Clinicas University of Sao Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
HCFMUSP-Hospital Clinicas da Faculdade Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
QC H1T2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHU de Bordeaux - Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Henri-Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital Edouard Herriot, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Montpellier, Hopital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology
City
Paris
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Européen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Saint Etienne, Hospital Nord
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Name
University Hospital Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Name
Rangueil Hospital-University Hospital Center (CHU) of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover, Studienzentrum fur Nieren und Hochdruckerkrankungen
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsmedizin Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Institute of Pediatric Nephrology
City
Petah Tikva
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Name
Policlinico di Bari
City
Bari
ZIP/Postal Code
70123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Sant Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Universita degli Studi di Messina
City
Messina
ZIP/Postal Code
98125
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
City
Milano
ZIP/Postal Code
20156
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Instituti Clinici Scientifici Maugeri SPA-IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Pediatrico Bambino Gesu
City
Rome
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aichi Children's Health and Medical Center
City
Ōbu
State/Province
Aichi
ZIP/Postal Code
474-8710
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Kanazawa Medical Center
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
9208650
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitano Hospital
City
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yonsei University College of Medicine, Sinchon Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Soeul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Emma Kinderziekenhuis, Amsterdam UMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
Individual Site Status
Recruiting
Facility Name
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Recruiting
Facility Name
Fundació Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Materno-Infantil Vall d' Hebron, Nefrologia Pediatrica
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Materno Infantil Sant Joan de Deu
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre, Nephrology Department
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital of Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Dr Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Name
Inselspital, Bern University Hospital
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
CHUV Lausanne
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Universitatsspital Zurich
City
Zürich
ZIP/Postal Code
CH-8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Gloucestershire Hospitals NHS Foundation Trust
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Great Ormond Street Hospital Foundation Trust
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham Children's Hospital
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Links:
URL
https://theVALIANTstudy.com
Description
Study Website
Learn more about this trial
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
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