Estudio de fase 2a, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, multicéntrico, para evaluar la eficacia, seguridad, tolerabilidad, farmacocinética, farmacodinamia e inmunogenicidad de ALXN1920 en participantes adultos con nefropatía membranosa primaria (PMN) con alto riesgo de progresión de la enfermedad

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07157787Tipo: INTERVENTIONALInicio: 19 de sept de 2025Fin estimado: 12 de feb de 2027

Resumen

El objetivo primario de este estudio es evaluar la eficacia de ALXN1920 en comparación con placebo en participantes con PMN que presentan alto riesgo de progresión de la enfermedad, utilizando la relación proteína/creatinina en orina de 24 horas (UPCR).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 50 RU/mL) at Screening, which must be confirmed by a central laboratory
Participants are willing to receive the background Standard of Care (SoC)
Participants at high risk for disease progression, defined as:
Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants with less than 8 weeks on ACE inhibitor or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period.
Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure \< 140 mmHg in ≥ 75% of the readings within last 8 weeks.
Having two proteinuria measurements with each \> 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis

Criterios de exclusión

Estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m\^2 during Screening
Documented rapid deterioration of kidney function
History of life-threatening Nephrotic Syndrome within 1 year before Screening
Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R \< 50 RU/mL or kidney disease other than PMN
History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period
History or presence of any clinically relevant co-morbidities
History of intolerance or hypersensitivity to ACEi or ARB
Use of SGLT2i, MRA, or ERA within 8 weeks prior to randomization and throughout the study period

Intervenciones

drug

ALXN1920

Participants will receive ALXN1920 SC infusion.

drug

Placebo

Participants will receive Placebo SC infusion.

Ubicaciones

Research Site

Buenos Aires, Argentina

RECRUITING

Research Site

CABA, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, Argentina

RECRUITING

Research Site

Rosario, Argentina

RECRUITING

Research Site

Santa Fe, Argentina

WITHDRAWN

Research Site

Santa Fe, Argentina

WITHDRAWN

Patrocinadores

PrincipalAlexion Pharmaceuticals, Inc.

ColaboradorAstraZeneca

Contactos

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

clinicaltrials@alexion.com 1-855-752-2356

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Estudio de fase 2a, aleatorizado, doble ciego, controlado... | EligiMed