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New hope for kidney patients: drug may stop protein leak without lifelong pills

NCT ID NCT04629248

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tests a drug called obinutuzumab against a standard treatment (tacrolimus) in 142 adults with primary membranous nephropathy, a kidney disease that lets protein leak into urine. The goal is to see if obinutuzumab can bring about complete remission (no protein in urine) by week 104. Participants must have severe protein leakage and adequate kidney function. The drug is given by infusion, and while it aims to control the disease, patients may still need ongoing monitoring or other medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

142 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

idiopathic membranous glomerulonephritis membranous glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary membranous nephropathy

Contacts and locations

Locations

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    Brescia, Lombardy, 25123, Italy

  • A.O. U. Federico II

    Naples, Campania, 80131, Italy

  • ASST Monza - Ospedale San Gerardo

    Monza, Lombardy, 20900, Italy

  • Accel Research Sites; Mid-Florida Kidney and Hypertension Care

    Altamonte Springs, Florida, 32701, United States

  • Akdeniz University Medical Faculty

    Antalya, 07059, Turkey (Türkiye)

  • CINME

    Buenos Aires, C1056ABI, Argentina

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Ege Uni School of Medicine

    Izmir, 35100, Turkey (Türkiye)

  • First Moscow State Medical University n.a. I.M. Sechenov

    Moscow, Moscow Oblast, 119021, Russia

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004, China

  • German clinic

    Saint Petersburg, Sankt-Peterburg, 196070, Russia

  • Hacettepe Uni School of Medicine

    Ankara, 06100, Turkey (Türkiye)

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hopital Rangueil

    Toulouse, 31059, France

  • Hopital Tenon

    Paris, 75020, France

  • Hospital Britanico Buenos Aires

    Buenos Aires, C1280AEB, Argentina

  • Hospital Clinic i Provincial

    Barcelona, 08036, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

    São Paulo, São Paulo, 04038-002, Brazil

  • Huashan Hospital, Fudan University

    Shanghai, 200040, China

  • Kaiser Permanente - San Francisco Medical Center

    San Francisco, California, 94118, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515, China

  • Nephrotex Research Group

    Dallas, Texas, 75231, United States

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO, Argentina

  • Ospedale San Giovanni Bosco

    Turin, Piedmont, 10154, Italy

  • Peking University First Hospital

    Beijing, 100034, China

  • Policlinico di Bari

    Bari, Apulia, 70124, Italy

  • Rostov State Medical Uni

    Rostov-on-Don, Rostov Oblast, 344022, Russia

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025, China

  • Ser Servicos Especializados Em Reumatologia

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Sheba MC

    Ramat Gan, 52621, Israel

  • Sichuan Provincial People's Hospital

    Chengdu, 610072, China

  • Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy

    Bydgoszcz, 85-094, Poland

  • The 1st Affiliated hospital of Fujian Medical University

    Fuzhou, 350005, China

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061, China

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030, China

  • University of Colorado in Denver-Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • Uniwersytecki Szpital Kliniczny im WAM CSW

    ?ód?, 92-213, Poland

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroc?aw, 50-556, Poland

  • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

    ?ód?, 90-153, Poland

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bia?ystok, 15-276, Poland

  • Zhejiang Provincial People?s Hospital

    Hangzhou, Zhejiang, 310014, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.