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Terminado antes de tiempoNCT05162066Registro de ClinicalTrials.gov

Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)

Complement 3 Glomerulopathy · Immunoglobulin A Nephropathy · Membranous Nephropathy

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
Fase 2
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
2 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Por qué se detuvo el estudio

Sponsor Decision

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The objective of this study was to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

  • Body weight ≥ 40 kilograms (kg)
  • Primary diagnosis of C3G, IgAN, or PMN confirmed by central pathology review
  • An estimated glomerular filtration rate (eGFR) ≥ 50 milliter per minute per 1.73 meter square (mL/min/1.73 m\^2) (or ≥ 30 mL/min/1.73 m\^2 after Data Monitoring Committee \[DMC\] recommendation)
  • Receiving treatment with a stable, maximum recommended or maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 60 days prior to the Day 1 Visit
  • Documentation of current vaccinations against Neisseria meningitidis and Streptococcus pneumoniae or willingness to start vaccination series

Exclusion Criteria:

  • Known congenital deficiency of C1s, C1r, C1q, C2, or C4
  • History of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation
  • Myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition
  • History of malignancy within 5 years prior to the screening visit
  • Active serious bacterial, viral, or fungal infection or any other serious infection within 14 days of screening
  • Treatment with any systemic immunosuppressive or immunomodulatory therapy within 90 days OR anti-CD20 antibody therapies (eg, rituximab) within 180 days prior to the screening visit
  • Treatment with renin inhibitors (eg, aliskiren) or sodium-glucose-cotransporter 2 (SGLT2) inhibitors within 60 days prior to Day 1
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Sin asignación al azar
Enmascaramiento
Sin enmascaramiento
C3G cohort

Approximately 14 eligible participants with C3G will be enrolled.

Drug: BCX9930

IgAN cohort

Approximately 14 eligible participants with IgAN will be enrolled.

Drug: BCX9930

PMN cohort

Approximately 14 eligible participants with PMN will be enrolled.

Drug: BCX9930

BCX9930 DRUG

Administered orally at a dose of 200 mg twice daily for the first 2 weeks, then 400 mg twice daily

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Percent Change From Baseline in 24-hour uPCR at Week 12

Plazo: Baseline, Week 12

Urinary protein/creatinine ratio (mg/mmol) =urine protein concentration (mg/dL)/ urine creatinine concentration (mmol/dL). Decrease of urinary protein/creatinine ratio means improvement of renal disease.

Percent Change From Baseline in 24-hour uPCR at Week 24

Plazo: Baseline, Week 24

Urinary protein/creatinine ratio (mg/mmol) =urine protein concentration (mg/dL)/ urine creatinine concentration (mmol/dL). Decrease of urinary protein/creatinine ratio means improvement of renal disease.

Medidas secundarias

Percent Change From Baseline in 24-hour Urinary Protein Excretion

Plazo: Baseline, Weeks 12, 24,

No informado en este registro.

Change From Baseline in Estimated Glomerular Filtration Rate

Plazo: Baseline, Weeks 12, 24

eGFR was calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula for participants ≥ 18 years old and by the bedside Schwartz formula for participants ≤ 18 years old. eGFR was reported in milliliter per minute per 1.73 per square meter (mL/min/1.73m\^2).

Number of Participants With a Treatment-emergent Adverse Event (TEAE)

Plazo: From first dose up to safety follow-up period (Week 28)

An Adverse event (AE) was any untoward medical occurrence in a clinical study participant. TEAEs were defined, within a dosing group, as AEs that started on or after the first dose of study treatment through 30 days after the last dose of study drug.

Number of Participants Who Discontinued Due to a TEAE

Plazo: From first dose up to safety follow-up period (Week 28)

An AE was any untoward medical occurrence in a clinical study participant. TEAEs were defined, within a dosing group, as AEs that started on or after the first dose of study treatment through 30 days after the last dose of study drug.

Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE)

Plazo: From first dose up to safety follow-up period (Week 28)

An AE was any untoward medical occurrence in a clinical study participant. TEAEs were defined, within a dosing group, as AEs that started on or after the first dose of study treatment through 30 days after the last dose of study drug.

A serious adverse event (SAE) was an adverse event/reaction that results in any of the following outcomes:

  • Death
  • Is life-threatening (participant was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe)
  • Requires participant hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity (ie, there was a substantial disruption of a person's ability to carry out normal life functions)
  • Is a congenital anomaly/birth defect
Number of Participants Who Experienced a Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 TEAE

Plazo: From first dose up to safety follow-up period (Week 28)

An AE was any untoward medical occurrence has no causal relationship with the study drug or with the clinical study itself. It was an unfavorable \& unintended sign, symptom, syndrome, or illness that developed or worsened during clinical study.

TEAEs: AEs that started on or after first dose of treatment through 30 days after the last dose of study drug. All AEs were graded using the CTCAE Grades 1 through 5.

Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated

Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL)

Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL

Grade 4: Life-threatening consequences; urgent intervention indicated

Grade 5: Death

Participants with Grades 3 or 4 AEs were reported

Number of Participants Who Experienced a CTCAE Treatment-emergent Grade 3 or 4 Laboratory Abnormality

Plazo: From first dose up to safety follow-up period (Week 28)

Treatment-emergent Laboratory Abnormality were defined as an event that started on or after the first dose of study treatment through 30 days after the last dose of study drug.

CTCAE Grades for laboratory abnormalities include:

Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.

Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.

Grade 4: Life-threatening consequences; urgent intervention indicated.

Grade 5: Death

Participants with Grades 3 or 4 laboratory abnormality were reported.

Hay resultados publicados en el registro.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (11)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

11 centros

Investigative SitePoitiers, FranceEstado desconocido
Investigative SiteToulouse, FranceEstado desconocido
Investigative SiteBari, ItalyEstado desconocido
Investigative SiteBergamo, ItalyEstado desconocido
Investigative SiteBrescia, ItalyEstado desconocido
Investigative SiteTurin, ItalyEstado desconocido
Investigative Site #1Barcelona, SpainEstado desconocido
Investigative Site #2Barcelona, SpainEstado desconocido
Investigative Site #1Madrid, SpainEstado desconocido
Investigative Site #2Madrid, SpainEstado desconocido
Investigative SiteOxford, United KingdomEstado desconocido

Equipo y fechas

Patrocinador principal
BioCryst Pharmaceuticals
Inicio del estudio
18 feb 2022 Real
Finalización primaria
23 sept 2022 Real
Finalización del estudio
23 sept 2022 Real
Primera publicación
17 dic 2021 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects With Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026