A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

NCT04629248 · tracked via the Priya Life Science China tracker

Sponsor

Hoffmann-La Roche

Phase

Phase 3

Started

2021-06-25

Last updated

2026-07-07

Condition(s) studied

Primary Membranous Nephropathy

Investigational drug(s) / intervention(s)

ObinutuzumabTacrolimusMethylprednisoloneAcetaminophenDiphenhydramine

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.

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.

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

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.

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.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 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 * Other inclusion criteria may apply Exclusion Criteria: * 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 * Other exclusion criteria may apply

Primary outcome measure(s)

Percentage of Participants who Achieve a Complete Remission (CR) at Week 104 — Week 104

Trial sites (50)

Facility	City	Region
Kaiser Permanente - San Francisco Medical Center	San Francisco	California
University of Colorado in Denver-Anschutz Medical Campus	Aurora	Colorado
Accel Research Sites; Mid-Florida Kidney and Hypertension Care	Altamonte Springs	Florida
University of Iowa	Iowa City	Iowa
Henry Ford Hospital	Detroit	Michigan
Mayo Clinic	Rochester	Minnesota
Columbia University Medical Center	New York	New York
Nephrotex Research Group	Dallas	Texas
Organizacion Medica de Investigacion	Buenos Aires	Argentina
CINME	Buenos Aires	Argentina
Hospital Britanico Buenos Aires	Buenos Aires	Argentina
Ser Servicos Especializados Em Reumatologia	Salvador	Estado de Bahia
Hospital de Base de Sao Jose do Rio Preto	São José do Rio Preto	São Paulo
Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos	São Paulo	São Paulo
Hospital das Clinicas - FMUSP	São Paulo	São Paulo
Zhejiang Provincial People?s Hospital	Hangzhou	Zhejiang
Peking University First Hospital	Beijing	China
Sichuan Provincial People's Hospital	Chengdu	China
The 1st Affiliated hospital of Fujian Medical University	Fuzhou	China
Nanfang Hospital, Southern Medical University	Guangzhou	China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	China
Huashan Hospital, Fudan University	Shanghai	China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	China
The First Affiliated Hospital of Xian Jiao Tong University	Xi'an	China
General Hospital of Ningxia Medical University	Yinchuan	China
Hopital Henri Mondor	Créteil	France
Hopital Tenon	Paris	France
Hopital Rangueil	Toulouse	France
Sheba MC	Ramat Gan	Israel
Policlinico di Bari	Bari	Apulia
A.O. U. Federico II	Naples	Campania
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili	Brescia	Lombardy
ASST Monza - Ospedale San Gerardo	Monza	Lombardy
Ospedale San Giovanni Bosco	Turin	Piedmont
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego	?ód?	Poland
Uniwersytecki Szpital Kliniczny im WAM CSW	?ód?	Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku	Bia?ystok	Poland
Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy	Bydgoszcz	Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroc?aw	Poland
First Moscow State Medical University n.a. I.M. Sechenov	Moscow	Moscow Oblast

+ 10 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04629248 on ClinicalTrials.gov ↗ ← All trials in China