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New drug aims to stop kidney disease from coming back after transplant

NCT ID NCT04572854

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tested a drug called pegcetacoplan in 13 kidney transplant patients whose original kidney disease (C3G or IC-MPGN) had come back. The goal was to see if the drug could reduce signs of disease activity in the kidney. The study was small and early-stage, so results are not conclusive, but it may point toward a new way to manage this difficult condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pegcetacoplan
What this could lead to
If it works, this could offer a way to control recurring kidney disease after transplant, potentially preserving the transplant longer.
What could go wrong
This is a very small, early-phase study with only 13 participants. The results may not apply to all patients, and the drug may not prove effective or safe in larger trials.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

13 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2026

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

18 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: * At least 18 years of age at screening * Must have clinical and pathologic evidence of recurrent C3G or IC-MPGN * Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan * eGFR ≥15 mL/min/1.73 m2, calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation for adults * No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal allograft biopsy * Stable regimen for recurrent C3G/IC-MPGN for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization * Have received required vaccinations against N. meningitidis, S. pneumoniae, and H. influenzae (type B) or agree to receive vaccinations, if applicable vaccination records are not available. Vaccination is mandatory unless documented evidence exists that subjects are non-responders to vaccination. Exclusion Criteria: * Absolute neutrophil count \<1000 cells/mm3 during screening * Previous treatment with pegcetacoplan * Evidence of rejection on the screening renal allograft biopsy that requires treatment * Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection with any of these viruses * Weight more than 100 kg at screening * Hypersensitivity to pegcetacoplan or 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 * Significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection, or a medication) that would, in the opinion of the investigator, confound interpretation of the study results * Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives from the last dose of the investigational agent (whichever is longer) prior to screening * 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 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) Dense deposit disease (DDD) Ic-MPGN Immune complex membranoproliferative glomerulonephritis (ic-MPGN) Membranoproliferative glomerulonephritis Membranoproliferative glomerulonephritis (MPGN) Renal transplant

Contacts and locations

Locations

  • CHUV

    Lausanne, 1005, Switzerland

  • CUIMC

    New York, New York, 10032, United States

  • Center Hospitalier Universitaire de Montpellier

    Montpellier, 34295 CEDEX 5, France

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, 05403-000, Brazil

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Hopital Edouard Herriot, Hospices Civils de Lyon

    Lyon, 69437, France

  • Hospital Universitario 12 de Octubre, Nephrology Department

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Favaloro

    Buenos Aires, C1093AAS, Argentina

  • Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner

    San Juan Bautista, Buenos Aires, B1888AAE, Argentina

  • Imperial College Healthcare NHS Trust

    London, W12 0HS, United Kingdom

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

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

  • Istituto di Ricerche Farmacologiche Mario Negri IRCCS

    Ranica, 24020, Italy

  • Keck School of Medicine, University of Southern California

    Los Angeles, California, 900033, United States

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

    Lille, 59000, France

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Medical University of Vienna

    Vienna, 1090, Austria

  • Monash Medical Centre

    Clayton, 3168, Australia

  • NYU Langone Health Transplant Insitute

    New York, New York, 10016, United States

  • Radbound University Medical Center

    Nijmegen, 6500 HB, Netherlands

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, CEP 30150-221, Brazil

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP

    Botucatu, São Paulo, 18618-686, Brazil

  • Washington University, St.Louis

    St Louis, Missouri, 63110, United States

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