A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04629248Tipo: INTERVENTIONALInicio: 25 de jun de 2021Fin estimado: 21 de dic de 2027

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening
Screening urinary protein-to-creatinine ratio (UPCR) \>= 5 g/g from 24-hour urine collection after best supportive care for \>= 3 months prior to screening or screening UPCR \>= 4 g/g after best supportive care for \>= 6 months prior to screening
eGFR \>= 40 mL/min/1.73m\^2 or qualified endogenous creatinine clearance \>= 40 mL/min/1.73m\^2 based on 24-hour urine collection during screening

Criterios de exclusión

Participants with a secondary cause of MN
Pregnancy or breastfeeding
Evidence of \>= 50% reduction in proteinuria during the previous 6 months prior to randomization
Severe renal impairment, including the need for dialysis or renal replacement therapy
Type 1 or 2 diabetes mellitus
Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to or during screening
Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude participant participation
Known active infection of any kind or recent major episode of infection
Major surgery requiring hospitalization within the 4 weeks prior to screening
Current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening
Intolerance or contraindication to study therapies

Intervenciones

drug

Obinutuzumab

Open Label: An intravenous (IV) infusion of 1000 milligram (mg) of obinutuzumab will be administered at Week 0, Week 2, Week 24, and Week 26. Participants who relapse during the open-label treatment period may be eligible for further treatment.

drug

Tacrolimus

Open Label: Participants will receive tacrolimus at a starting oral dose (PO) of 0.05 mg/kilogram (kg) (participant dry weight) per day divided into two equal doses given at 12-hour intervals, titrated to serum trough level 5-7 Nanograms per millilitre (ng/mL). Optimized tacrolimus dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks. Participants who relapse during the open-label treatment period will have their dose of tacrolimus tapered over 8 weeks and may be eligible for further treatment.

drug

Methylprednisolone

Premedication: Methylprednisolone 80 mg IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.

drug

Acetaminophen

Premedication: Acetaminophen (650-1000 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.

drug

Diphenhydramine

Premedication: Diphenhydramine (50 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.

Ubicaciones

Organizacion Medica de Investigacion

Buenos Aires, Argentina

CINME

Buenos Aires, Argentina

Hospital Britanico Buenos Aires

Buenos Aires, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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