Resumen

El propósito de este estudio es evaluar la eficacia, la seguridad y la farmacocinética de sefaxersen (RO7434656), una novedosa terapia con oligonucleótido antisentido (ASO), en participantes con nefropatía primaria por IgA (NIgA) que presentan alto riesgo de enfermedad renal progresiva a pesar de un tratamiento de soporte optimizado.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause
Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening, and without an intent to modify the dose during the study, except for interruptions due to illness (not greater than 7 consecutive days), unless the potential participant is intolerant to these medications
Urine Protein-to-Creatinine Ratio (UPCR) ≥ 1 gram per gram (g/g) or urine protein excretion ≥ 1 gram per day (g/day) (with UPCR ≥ 0.8 g/g), all measured from a 24-hour urine collection during screening
eGFR ≥ 20 mL/min/1.73 m\^2, as calculated by the 2021 CKD-EPI creatinine equation (Inker et al. 2021a)
Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to national vaccination recommendations
Female participants of childbearing potential must use adequate contraception

Criterios de exclusión

Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of sefaxersen
Histopathologic or other evidence of another autoimmune glomerular disease
Presence of ≥ 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator
History of kidney transplantation
Glycated Hemoglobin (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type
Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg from the average of two measurements performed at least 1 minute apart during screening
Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitors within 16 weeks prior to screening or during screening
Initiation of endothelin receptor antagonists within 90 days prior to screening or during screening
Initiation of mineralocorticoid receptor antagonists or non-dihydropyridine calcium channel blockers within 90 days prior to screening or during screening
Use of herbal therapies within 90 days prior to or during screening
Treatment with investigational therapy within 28 days prior to screening or 5.5 drug-elimination half-lives of that investigational product prior to screening
Treatment with an investigational therapy planned during the treatment period
Previous treatment with sefaxersen
Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to ≥ 7.5 milligrams per day (mg/day) of prednisone for 7 days or equivalent to ≥ 5 mg/day of prednisone for 14 days within 90 days prior to screening
Treatment with corticosteroids with systemic effects during screening
Treatment with a systemic calcineurin inhibitor within 2 months prior to screening or during screening
Treatment with anti-CD20 therapy within 9 months of screening or during screening
Treatment with other systemic immunosuppressive agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), azathioprine, or mycophenolate
Planned major procedure or major surgery during screening or the study
Substance abuse within 12 months prior to screening or during screening
Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
History of malignancy within \< 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Usage of Glucagon-like Peptide-1 (GLP-1)-based therapy (i.e., GLP-1 mono-agonists, GLP-1/GIP dual agonists, etc.) within 90 days prior to screening or during screening, or intent to initiate during the study period

Ubicaciones

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Consultorios Médicos Dr. Doreski

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Sanatorio Mayo Privado

Córdoba, Argentina

RECRUITING

Sanatorio Allende

Córdoba, Argentina

RECRUITING

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

RECRUITING

Estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de sefaxersen, un inhibidor antisentido del factor B del complemento, en pacientes con nefropatía primaria por IgA con alto riesgo de progresión

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Sefaxersen (RO7434656)

Placebo

Ubicaciones

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Consultorios Médicos Dr. Doreski

Sanatorio Mayo Privado

Sanatorio Allende

Instituto Medico de la Fundacion Estudios Clinicos

Patrocinadores

Contactos

WA43966 https://forpatients.roche.com/