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Hope for rare kidney patients: new drug shows promise in phase 3 trial

NCT ID NCT05067127

Disease control Sponsor: Apellis Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called pegcetacoplan in 124 adults and teens with two rare kidney diseases (C3G and IC-MPGN). The goal was to see if the drug could reduce protein in the urine, a sign of kidney damage. Participants received either the drug or a placebo twice a week for 26 weeks. The results will help determine if pegcetacoplan can slow or improve kidney disease in these patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

124 people

The number who actually took part.

Started

Nov 2021

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged at least 18 years; where approved, adolescents (aged 12-17 years) weighing at least 30 kg may also be enrolled. 2. A diagnosis of primary C3G or IC-MPGN (with or without previous renal transplant). 3. Evidence of active renal disease, based on one or more of the following: 1. 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. 2. 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. 4. No more than 50% global glomerulosclerosis or interstitial fibrosis on the baseline biopsy for adult participants or adolescent participants providing a baseline biopsy. 5. 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. 6. 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. 7. Stable regimen for C3G/IC-MPGN treatment, as described below: 1. 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 2. 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. 3. 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. 8. 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: 1. Previous exposure to pegcetacoplan. 2. 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. 3. 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. 4. Body weight greater than 100 kg at screening. 5. Hypersensitivity to pegcetacoplan or to any of the excipients. 6. History of meningococcal disease. 7. Malignancy, except for the following: 1. Cured basal or squamous cell skin cancer 2. Curatively treated in situ disease 3. Malignancy-free and off treatment for ≥5 years 8. Severe infection (eg, requiring IV antibiotic therapy) within 14 days prior to the first dose of pegcetacoplan. 9. An absolute neutrophil count \<1000 cells/mm3 at screening. 10. 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. 11. 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. 12. 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. 13. Known or suspected hereditary fructose intolerance.

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Conditions

The condition(s) this trial relates to.

C3 glomerulonephritis complement 3 glomerulopathy dense deposit disease Dowling-Degos disease 1 immunoglobulin-mediated membranoproliferative glomerulonephritis membranoproliferative glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

C3 glomerulonephritis C3 glomerulopathy C3G Complement 3 glomerulonephritis Complement 3 glomerulopathy Complement 3 glomerulopathy (C3G) DDD Dense deposit disease Ic-MPGN Immune complex membranoproliferative glomerulonephritis (ic-MPGN) Membranoproliferative glomerulonephritis Membranoproliferative glomerulonephritis (MPGN)

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Academic Medical Research Institute

    Los Angeles, California, 90022, United States

  • Aichi Children's Health and Medical Center

    Ōbu, Aichi-ken, 474-8710, Japan

  • Azienda Ospedaliera Universitaria di Padova (39011)

    Padova, 35128, Italy

  • Boston Children's Hospital (01013)

    Boston, Massachusetts, 02115, United States

  • CHU Montpellier, Hopital Lapeyronie

    Montpellier, 34295, France

  • CHU Sart-Tilman

    Liège, B-4000, Belgium

  • CHU de Bordeaux - Hopital Pellegrin

    Bordeaux, 33076, France

  • CHU de Saint Etienne, Hospital Nord

    Saint-Priest-en-Jarez, 42055, France

  • CHUV Lausanne

    Lausanne, CH-1011, Switzerland

  • CUIMC - Columbia Nephrology

    New York, New York, 10032, United States

  • Canberra Hospital - Renal Clinical Trials & Research Unit

    Garran, Australian Capital Territory, 2605, Australia

  • Catholic University of Leuven

    Leuven, B-3000, Belgium

  • Centro de Tratamento de Doencas Renais

    Juiz de Fora, Minas Gerais, 36025-340, Brazil

  • Charite Universitatsmedizin (49007)

    Berlin, 10117, Germany

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64102, United States

  • Clinica Privada Velez Sarsfield

    Córdoba, X5000, Argentina

  • Clinical Trials CHU de Liège

    Liège, B-4000, Belgium

  • Cohen Children Hospital

    New Hyde Park, New York, 11040, United States

  • Emma Kinderziekenhuis, Amsterdam UMC

    Amsterdam, 1105 AZ, Netherlands

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Evelina London Children Hospital (44016)

    London, SE1 7EH, United Kingdom

  • Faculty Hospital Kralovske Vinohrady (42002)

    Prague, Czechia

  • Fides Clinical Research, LLC (01042)

    Atlanta, Georgia, 30342, United States

  • Fundació Puigvert

    Barcelona, 08025, Spain

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucester, GL1 3NN, United Kingdom

  • Great Ormond Street Hospital Foundation Trust

    London, WC1N 3JH, United Kingdom

  • Gunma University Hospital (81006)

    Maebashi, Gunma, 371-8511, Japan

  • HC UNESP Botucatu

    Botucatu, 18618-687, Brazil

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

    São Paulo, 05403-900, Brazil

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601, United States

  • Hopital Erasme HUB Service Pharmacie

    Brussels, 1070, Belgium

  • Hopital Henri-Mondor

    Créteil, 94010, France

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, QC H1T2M4, Canada

  • Hopital Necker (33014)

    Paris, 75015, France

  • Hospital Edouard Herriot, Hospices Civils de Lyon

    Lyon, 69437, France

  • Hospital Materno Infantil Sant Joan de Deu

    Barcelona, 08950, Spain

  • Hospital Privado-Universitario de Cordoba

    Córdoba, CPA X5016KEH, Argentina

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre, Nephrology Department

    Madrid, 28041, Spain

  • Hospital Universitario Austral

    Buenos Aires, 1629, Argentina

  • Hospital Universitario Dr Peset

    Valencia, 46017, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

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

    Barcelona, 08035, Spain

  • Hospital Universitario Walter Cantidio

    Fortaleza, 60430-372, Brazil

  • Hospital das Clinicas de Ribeirao Preto, Division of Nephrology

    Ribeirão Preto, 14110-000, Brazil

  • Hospital de Base

    São José do Rio Preto, 150900-000, Brazil

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Hospital for Sick Children (11003)

    Toronto, Ontario, M5G 1X8, Canada

  • Hôpital Européen Georges-Pompidou

    Paris, 75015, France

  • IRCCS Istituto Giannina Gaslini (39012)

    Genova, 16147, Italy

  • Imperial College Healthcare NHS Trust

    London, W12 0HS, United Kingdom

  • Inselspital, Bern University Hospital

    Bern, CH-3010, Switzerland

  • Institute for Clinical and Experimental Medicine

    Prague, 140 21, Czechia

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

    Chicago, Illinois, 60611, United States

  • Institute of Pediatric Nephrology

    Petah Tikva, 4920235, Israel

  • Instituti Clinici Scientifici Maugeri SPA-IRCCS

    Pavia, 27100, Italy

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

    São Paulo, 05403-000, Brazil

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090, Brazil

  • Istituto di Ricerche Farmacologiche Mario Negri IRCCS

    Milan, 20156, Italy

  • Keck School of Medicine, University of Southern California

    Los Angeles, California, 90033, United States

  • Keimyung University Dongsan Medical Center

    Daegu, 42601, South Korea

  • Kitano Hospital

    Osaka, 530-8480, Japan

  • Kyorin University Hospital (81009)

    Tokyo, 181-8611, Japan

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

    Paris, 59037, France

  • MedResearch Inc

    El Paso, Texas, 79902, United States

  • Medical University Hospital Innsbruck (43004)

    Innsbruck, 6020, Austria

  • Medizinische Hochschule Hannover, Studienzentrum fur Nieren und Hochdruckerkrankungen

    Hanover, 30625, Germany

  • Medizinische Universität Wien

    Vienna, A-1090, Austria

  • Monash University

    Box Hill, VIC 3128, Australia

  • NANIU Research Chicago (01040)

    Oak Brook, Illinois, 60523, United States

  • NHO Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 9208650, Japan

  • Nagasaki University Hospital (81005)

    Nagasaki, Nagasaki, 852-8501, Japan

  • Nagoya University Hospital (81003)

    Nagoya, Aichi-ken, 466-8560, Japan

  • Nantes University Hospital

    Nantes, 44093, France

  • Nefrologia I-Dor

    Rio de Janeiro, 22211-225, Brazil

  • Nephrology Associates of Northern IL and Inn (01043)

    Fort Wayne, Indiana, 46804, United States

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017, United States

  • Nottingham Children's Hospital

    Nottingham, NG7 2UH, United Kingdom

  • Oregon Health & Science University (01038)

    Portland, Oregon, 97239, United States

  • Ospedale Pediatrico Bambino Gesu

    Rome, 00165, Italy

  • Policlinico Sant Orsola-Malpighi

    Bologna, 40138, Italy

  • Policlinico di Bari

    Bari, 70123, Italy

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, QLD 4102, Australia

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102, Australia

  • Radboud University Medical Center

    Nijmegen, 6500 HB, Netherlands

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

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

    Toulouse, 31059, France

  • Real Hospital Portuguas de Beneficancia em Pernambuco

    Recife, 52010-095, Brazil

  • Renal and Transplant Associates of New England, PC

    Springfield, Massachusetts, 01107, United States

  • Ronald Reagan UCLA Medical Center (01035)

    Los Angeles, California, 90095, United States

  • Royal Free London NHS Foundation Trust (44015)

    London, NW3 2QG, United Kingdom

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL, United Kingdom

  • Ruschel Medicina E Pesquisa Clinica

    Rio de Janeiro, 22270-060, Brazil

  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Lodz, 92-213, Poland

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

    Lodz, 90-153, Poland

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Seirei Hamamatsu General Hospital (81004)

    Hamamatsu, Shizuoka, 430-8558, Japan

  • Seoul National University Hospital

    Soeul, 03080, South Korea

  • Seoul National University Hospital (82005)

    Seoul, 3080, South Korea

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

    London, SW17 0QT, United Kingdom

  • St. Vincents Melbourne

    Fitzroy, VIC 3065, Australia

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • The University of Iowa

    Iowa City, Iowa, 52242, United States

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

    Sacramento, California, 95817, United States

  • UCI Center for Clinical Research

    Orange, California, 92868, United States

  • UNIFESP - Hospital Sao Paulo

    São Paulo, 04038-002, Brazil

  • Universita degli Studi di Messina

    Messina, 98125, Italy

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

    Essen, D-45147, Germany

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • Universitatsmedizin Mainz

    Mainz, 55131, Germany

  • Universitatsspital Zurich

    Zurich, CH-8091, Switzerland

  • University Hospital Antwerp (32004)

    Edegem, 2650, Belgium

  • University Hospital Regensburg (49004)

    Regensburg, 93053, Germany

  • University Hospital Strasbourg

    Strasbourg, 67091, France

  • University Hospital of Virgen del Rocio

    Seville, 41013, Spain

  • University Hospitals of Leicester NHS trust (44003)

    Leicester, LE1 5WW, United Kingdom

  • University Medical Center Groningen

    Groningen, 9713 GZ, Netherlands

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • Yonsei University College of Medicine, Sinchon Severance Hospital

    Seoul, 03722, South Korea

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