New drug aims to stop kidney disease from coming back after transplant
NCT ID NCT04572854
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
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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
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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
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHUV
Lausanne, 1005, Switzerland
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CUIMC
New York, New York, 10032, United States
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Center Hospitalier Universitaire de Montpellier
Montpellier, 34295 CEDEX 5, France
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000, Brazil
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Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
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Hopital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69437, France
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Hospital Universitario 12 de Octubre, Nephrology Department
Madrid, 28041, Spain
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Hospital Universitario Fundacion Favaloro
Buenos Aires, C1093AAS, Argentina
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Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner
San Juan Bautista, Buenos Aires, B1888AAE, Argentina
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Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
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Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
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Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Ranica, 24020, Italy
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Keck School of Medicine, University of Southern California
Los Angeles, California, 900033, United States
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Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology
Lille, 59000, France
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
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Medical University of Vienna
Vienna, 1090, Austria
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Monash Medical Centre
Clayton, 3168, Australia
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NYU Langone Health Transplant Insitute
New York, New York, 10016, United States
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Radbound University Medical Center
Nijmegen, 6500 HB, Netherlands
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Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, CEP 30150-221, Brazil
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The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
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UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Botucatu, São Paulo, 18618-686, Brazil
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Washington University, St.Louis
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a single injection drug calm the immune attack on kidneys?
- Can a targeted therapy tame rare kidney diseases in daily practice?
- Can a gene-silencing drug calm overactive complement in kidney disease?
- Could the type of anesthesia affect kidney transplant success?
- New drug aims to fight skin cancer in transplant patients
- New ultrasound technique could predict kidney transplant success without needles