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C3GPhase 3VALIANTNCT05067127

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

A Phase 3 study testing Pegcetacoplan in people with C3G and IC-MPGN, run by Apellis Pharmaceuticals, Inc. at 125 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
C3G, IC-MPGN, C3 Glomerulopathy
What is being tested?
Pegcetacoplan
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
125 sitesin 19 countries
Study dates
12 Nov 2021to 14 Jan 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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 12 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

125 sites in 19 countries.

125 sites in 19 countries

United States26 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Fides Clinical Research, LLC (01042)

    Atlanta, Georgia, 30342

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Boston Children's Hospital (01013)

    Boston, Massachusetts, 02115

  • Institute for Public Health and Medicine Northwestern University Northwestern University (01041)

    Chicago, Illinois, 60611

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • MedResearch Inc

    El Paso, Texas, 79902

  • Nephrology Associates of Northern IL and Inn (01043)

    Fort Wayne, Indiana, 46804

  • University of Florida

    Gainesville, Florida, 32610

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

  • Texas Children's Hospital

    Houston, Texas, 77030

  • The University of Iowa

    Iowa City, Iowa, 52242

  • Children's Mercy Hospital

    Kansas City, Missouri, 64102

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Keck School of Medicine, University of Southern California

    Los Angeles, California, 90033

  • Ronald Reagan UCLA Medical Center (01035)

    Los Angeles, California, 90095

  • Cohen Children Hospital

    New Hyde Park, New York, 11040

  • CUIMC - Columbia Nephrology

    New York, New York, 10032

  • NANIU Research Chicago (01040)

    Oak Brook, Illinois, 60523

  • UCI Center for Clinical Research

    Orange, California, 92868

  • Oregon Health & Science University (01038)

    Portland, Oregon, 97239

  • UC Davis Medical Center (Transplant Research) (01016)

    Sacramento, California, 95817

  • Renal and Transplant Associates of New England, PC

    Springfield, Massachusetts, 01107

Other trials in United States

Brazil15 sites

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • HC UNESP Botucatu

    Botucatu, 18618-687

  • Hospital Universitario Walter Cantidio

    Fortaleza, 60430-372

  • Centro de Tratamento de Doencas Renais

    Juiz de Fora, Minas Gerais, 36025-340

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Real Hospital Portuguas de Beneficancia em Pernambuco

    Recife, 52010-095

  • Hospital das Clinicas de Ribeirao Preto, Division of Nephrology

    Ribeirão Preto, 14110-000

  • Nefrologia I-Dor

    Rio de Janeiro, 22211-225

  • Ruschel Medicina E Pesquisa Clinica

    Rio de Janeiro, 22270-060

  • Hospital de Base

    São José do Rio Preto, 150900-000

  • UNIFESP - Hospital Sao Paulo

    São Paulo, 04038-002

  • Instituto da Crianca-Hospital das Clinicas University of Sao Paulo

    São Paulo, 05403-000

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

    São Paulo, 05403-900

Other trials in Brazil

France11 sites

  • CHU de Bordeaux - Hopital Pellegrin

    Bordeaux, 33076

  • Hopital Henri-Mondor

    Créteil, 94010

  • Hospital Edouard Herriot, Hospices Civils de Lyon

    Lyon, 69437

  • CHU Montpellier, Hopital Lapeyronie

    Montpellier, 34295

  • Nantes University Hospital

    Nantes, 44093

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

    Paris, 59037

  • Hopital Necker (33014)

    Paris, 75015

  • Hôpital Européen Georges-Pompidou

    Paris, 75015

  • CHU de Saint Etienne, Hospital Nord

    Saint-Priest-en-Jarez, 42055

  • University Hospital Strasbourg

    Strasbourg, 67091

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

    Toulouse, 31059

Other trials in France

Italy9 sites

  • Policlinico di Bari

    Bari, 70123

  • Policlinico Sant Orsola-Malpighi

    Bologna, 40138

  • IRCCS Istituto Giannina Gaslini (39012)

    Genova, 16147

  • Universita degli Studi di Messina

    Messina, 98125

  • Istituto di Ricerche Farmacologiche Mario Negri IRCCS

    Milan, 20156

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Ospedaliera Universitaria di Padova (39011)

    Padova, 35128

  • Instituti Clinici Scientifici Maugeri SPA-IRCCS

    Pavia, 27100

  • Ospedale Pediatrico Bambino Gesu

    Rome, 00165

Other trials in Italy

United Kingdom9 sites

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucester, GL1 3NN

  • University Hospitals of Leicester NHS trust (44003)

    Leicester, LE1 5WW

  • Royal Free London NHS Foundation Trust (44015)

    London, NW3 2QG

  • Evelina London Children Hospital (44016)

    London, SE1 7EH

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

    London, SW17 0QT

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

  • Great Ormond Street Hospital Foundation Trust

    London, WC1N 3JH

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL

  • Nottingham Children's Hospital

    Nottingham, NG7 2UH

Other trials in United Kingdom

Japan8 sites

  • Seirei Hamamatsu General Hospital (81004)

    Hamamatsu, Shizuoka, 430-8558

  • NHO Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 9208650

  • Gunma University Hospital (81006)

    Maebashi, Gunma, 371-8511

  • Nagasaki University Hospital (81005)

    Nagasaki, Nagasaki, 852-8501

  • Nagoya University Hospital (81003)

    Nagoya, Aichi-ken, 466-8560

  • Aichi Children's Health and Medical Center

    Ōbu, Aichi-ken, 474-8710

  • Kitano Hospital

    Osaka, 530-8480

  • Kyorin University Hospital (81009)

    Tokyo, 181-8611

Other trials in Japan

Spain8 sites

  • Fundació Puigvert

    Barcelona, 08025

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

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

    Barcelona, 08035

  • Hospital Materno Infantil Sant Joan de Deu

    Barcelona, 08950

  • Hospital Universitario 12 de Octubre, Nephrology Department

    Madrid, 28041

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • University Hospital of Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Dr Peset

    Valencia, 46017

Other trials in Spain

Germany6 sites

  • Charite Universitatsmedizin (49007)

    Berlin, 10117

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

    Essen, D-45147

  • Medizinische Hochschule Hannover, Studienzentrum fur Nieren und Hochdruckerkrankungen

    Hanover, 30625

  • Universitatsmedizin Mainz

    Mainz, 55131

  • Universitatsklinikum Munster

    Münster, 48149

  • University Hospital Regensburg (49004)

    Regensburg, 93053

Other trials in Germany

Australia5 sites

  • Monash University

    Box Hill, VIC 3128

  • St. Vincents Melbourne

    Fitzroy, VIC 3065

  • Canberra Hospital - Renal Clinical Trials & Research Unit

    Garran, Australian Capital Territory, 2605

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, QLD 4102

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102

Other trials in Australia

Belgium5 sites

  • Hopital Erasme HUB Service Pharmacie

    Brussels, 1070

  • University Hospital Antwerp (32004)

    Edegem, 2650

  • Catholic University of Leuven

    Leuven, B-3000

  • CHU Sart-Tilman

    Liège, B-4000

  • Clinical Trials CHU de Liège

    Liège, B-4000

Other trials in Belgium

South Korea4 sites

  • Keimyung University Dongsan Medical Center

    Daegu, 42601

  • Yonsei University College of Medicine, Sinchon Severance Hospital

    Seoul, 03722

  • Seoul National University Hospital (82005)

    Seoul, 3080

  • Seoul National University Hospital

    Soeul, 03080

Other trials in South Korea

Argentina3 sites

  • Hospital Universitario Austral

    Buenos Aires, 1629

  • Hospital Privado-Universitario de Cordoba

    Córdoba, CPA X5016KEH

  • Clinica Privada Velez Sarsfield

    Córdoba, X5000

Other trials in Argentina

Netherlands3 sites

  • Emma Kinderziekenhuis, Amsterdam UMC

    Amsterdam, 1105 AZ

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • Radboud University Medical Center

    Nijmegen, 6500 HB

Other trials in Netherlands

Switzerland3 sites

  • Inselspital, Bern University Hospital

    Bern, CH-3010

  • CHUV Lausanne

    Lausanne, CH-1011

  • Universitatsspital Zurich

    Zurich, CH-8091

Other trials in Switzerland

Austria2 sites

  • Medical University Hospital Innsbruck (43004)

    Innsbruck, 6020

  • Medizinische Universität Wien

    Vienna, A-1090

Other trials in Austria

Canada2 sites

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, QC H1T2M4

  • Hospital for Sick Children (11003)

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Czechia2 sites

  • Institute for Clinical and Experimental Medicine

    Prague, 140 21

  • Faculty Hospital Kralovske Vinohrady (42002)

    Prague

Other trials in Czechia

Israel2 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Institute of Pediatric Nephrology

    Petah Tikva, 4920235

Other trials in Israel

Poland2 sites

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

    Lodz, 90-153

  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Lodz, 92-213

Other trials in Poland

About this study

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

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.

Being tested
Pegcetacoplan, Placebo
Medical subject headings
Glomerulonephritis, Membranoproliferative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PegcetacoplanDrug

    Complement (C3) Inhibitor

  • PlaceboOther

    Sterile solution of equal volume to active arm

Study groups in NCT05067127
Study groupRoleWhat they receive
Group 1: Pegcetacoplan administrationExperimentalSubcutaneous 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)
Receives: Drug: Pegcetacoplan
Group 2: Placebo administrationPlacebo comparatorSubcutaneous infusion of either 10mL, 12mL, 15mL, or 20mL, twice weekly
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26

    Baseline uPCR value was calculated as the average of the uPCR measurements from at least 6 of the 9 first-morning spot urine (FMU) samples collected between the start of screening and Day 1, inclusive. The uPCR values used to calculate baseline included those from the samples collected on Day -2, Day -1, and before dosing on Day 1. In situations where less than 6 samples or more than 9 samples were collected, the average of all collected samples was used for baseline derivation. The difference between treatment groups using a composite contrast of equal-weighted average over Weeks 24, 25, and 26 was estimated.

    Measured: Baseline (Day -70 to Day 1) to Week 26

Secondary outcomes (10)

  1. Randomized Controlled Period: Percentage of Subjects Who Achieved the Composite Renal Endpoint at Week 26

    Subject who achieved a composite renal endpoint was defined as: (1) a stable or improved estimated glomerular filtration rate (eGFR) compared to baseline (<=15% reduction in eGFR), and (2) a >=50% reduction in uPCR compared to baseline. Percentages are rounded off to the hundredth decimal place.

    Measured: Week 26

  2. Randomized Controlled Period: Percentage of Subjects With a Reduction of At Least 50% From Baseline in Urine Protein-to-Creatinine Ratio at Week 26

    Baseline uPCR value was calculated as the average of the uPCR measurements from at least 6 of the 9 FMU samples collected between the start of screening and Day 1, inclusive. The uPCR values used to calculate baseline included those from the samples collected on Day -2, Day -1, and before dosing on Day 1. In situations where less than 6 samples or more than 9 samples were collected, the average of all collected samples was used for baseline derivation. Percentages are rounded off to the hundredth decimal place.

    Measured: Baseline (Day -70 to Day 1) and Week 26

  3. Randomized Controlled Period: Change From Baseline in the C3 Glomerulopathy (C3G) Histologic Index Activity Score at Week 26

    The C3G histologic index used to assess disease activity and chronicity in C3G. The C3G total activity score ranges from 0 (worse) to 21 (best). Higher scores indicate better outcome. Baseline was defined as the most recent non-missing measurement prior to taking the first dose of study drug.

    Measured: Baseline (Day 1) and Week 26

  4. Randomized Controlled Period: Percentage of Subjects Who Showed Decrease in C3c Staining on Renal Biopsy From Baseline at Week 26

    Subject who showed decrease in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Percentages are rounded off to the hundredth decimal place.

    Measured: Baseline (Day 1) and Week 26

  5. Randomized Controlled Period: Change From Baseline in Estimated Glomerular Filtration Rate at Week 26

    Serum samples were collected to determine the eGFR, calculated by using chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation for adults and the Bedside Schwartz equation for adolescents. Baseline eGFR value was calculated using the last non-missing assessment prior to first dose of study drug.

    Measured: Baseline (Day 1) and Week 26

  6. Randomized Controlled Period: Percentage of Subjects Who Achieved Proteinuria <1 Gram (g)/Day at Week 24

    Urine samples were collected to determine the proteinuria. Percentage of subjects who achieved proteinuria <1 g/day was assessed by 24-hour urine protein. Percentages are rounded off to the hundredth decimal place.

    Measured: Week 24

  7. Randomized Controlled Period: Percentage of Subjects With Normalization of Serum Albumin Levels at Week 26

    Baseline serum albumin value was calculated as the average of up to 2 serum albumin measurements preceding and including Day 1. Week 26 serum albumin values was calculated as the average of up to 2 serum albumin measurements preceding and including Week 26, no earlier than Week 20 measurement. Percentages are rounded off to the hundredth decimal place.

    Measured: Week 26

  8. Randomized Controlled Period: Percentage of Subjects With Serum C3 Levels Above the Lower Limit of Normal at Week 26

    Baseline serum C3 value was calculated as the average of up to 2 serum C3 measurements preceding and including Day 1. Week 26 serum C3 value was calculated as the average of up to 2 serum C3 measurements preceding and including Week 26, no earlier than Week 20 measurement. Percentages are rounded off to the hundredth decimal place.

    Measured: Week 26

  9. Randomized Controlled Period: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 26

    The FACIT-Fatigue scale was a 13-item Likert scaled instrument that was self-administered by subjects. Subjects were presented with 13 statements and asked to indicate their responses as it applied to the past 7 days. The 5 possible responses were "not at all" (0), "a little bit" (1), "somewhat" (2), "quite a bit" (3) and "very much" (4). With 13 statements the total score has a range of 0 (worse health-related quality of life) to 52 (best health-related quality of life). Higher scores indicate better quality of life. Baseline was defined as the most recent non-missing measurement prior to taking the first dose of study drug.

    Measured: Baseline (Day 1) and Week 26

  10. Randomized Controlled Period: Change From Baseline in the Kidney Disease Quality of Life (KDQOL) Score at Week 26

    The KDQOL score was constructed as the KDQOL-36 Summary Score (KSS) by averaging the 24 items from Burden of Kidney Disease, Symptoms and Problems of Kidney Disease, and Effects of Kidney Disease on scale ranging from 0 (worse health-related quality of life) to 100 (best health-related quality of life). Higher scores indicate better quality of life. Baseline was defined as the most recent non-missing measurement prior to taking the first dose of study drug.

    Measured: Baseline (Day 1) and Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start12 Nov 2021
  3. Primary completion26 Jun 2024
  4. Study completion14 Jan 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05067127
Sponsor's protocol ID
APL2-C3G-310
Acronym
VALIANT
Status last verified
Aug 2025
First submitted
23 Sep 2021
Last updated
29 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Vivarelli M, Ariceta G, Borovitz Y, Dixon BP, Greenbaum LA, Licht C, Mastrangelo A, Melhem N, Fujita N, van de Kar NCAJ, Wallace D, Khankin E, Wang Z, Lopez-Lazaro L, Szamosi J, Nester CM. Pegcetacoplan for Adolescents with C3 Glomerulopathy or Primary Immune Complex Membranoproliferative GN: Phase 3 VALIANT Subgroup Analysis. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1404-1413. doi: 10.2215/CJN.0000001077. Epub 2026 May 14.

    PubMed 42133432

  • Fakhouri F, Bomback AS, Ariceta G, Delmas Y, Dixon BP, Gale DP, Greenbaum LA, Han SH, Isbel N, Le Quintrec M, Licht C, Mastrangelo A, Mizuno M, Neves de Holanda MI, Pickering MC, Remuzzi G, Van De Kar N, Vivarelli M, Walker PD, Wallace D, Zecher D, Francois C, Deschatelets P, Li L, Wang Z, Abad-Franch L, Kinnman N, Lopez-Lazaro L, Szamosi J, Nester CM; VALIANT Trial Investigators Group. Trial of Pegcetacoplan in C3 Glomerulopathy and Immune-Complex MPGN. N Engl J Med. 2025 Dec 4;393(22):2210-2220. doi: 10.1056/NEJMoa2501510.

    PubMed 41337715

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegcetacoplan in people with C3G and IC-MPGN, run by Apellis Pharmaceuticals, Inc. at 125 sites in 19 countries.

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 17 inclusion and 16 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, Brazil, France, Italy, United Kingdom and 14 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26 (time frame: Baseline (Day -70 to Day 1) to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05067127, which also lists 2 linked publications.

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 29 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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