Estudio de fase 2, abierto, aleatorizado y controlado para evaluar la seguridad y eficacia de pegcetacoplan en el tratamiento de la recidiva postrasplante de C3G o IC-MPGN

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT04572854Tipo: INTERVENTIONALInicio: 7 de sept de 2021Fin estimado: 1 de ene de 2026

Resumen

Estudio de fase 2, multicéntrico, abierto, aleatorizado y controlado, diseñado para evaluar la seguridad y eficacia de pegcetacoplan en pacientes con recidiva postrasplante de C3G o IC-MPGN.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Pegcetacoplan

Complement (C3) Inhibitor

Ubicaciones

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

San Juan Bautista, Buenos Aires, Argentina

Hospital Universitario Fundacion Favaloro

Buenos Aires, Argentina

Patrocinadores

PrincipalApellis Pharmaceuticals, Inc.

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