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NCT04629248 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Primary Membranous Nephropathy, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 3
Development phase
142
Enrollment target
20
Study locations

NCT04629248 is a Phase 3 study of Primary Membranous Nephropathy that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 142 participants, above the 119-participant average among 8 other Primary Membranous Nephropathy trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT04629248, a Phase 3 study of Primary Membranous Nephropathy, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
142 participants
Enrollment target
20
Study locations

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).

Conditions Studied

Primary Membranous Nephropathy

Interventions

  • DRUG Obinutuzumab
  • DRUG Acetaminophen
  • DRUG Methylprednisolone
  • DRUG Diphenhydramine
  • DRUG Tacrolimus

Study Locations (20)

Other

  • Organizacion Medica de Investigacion - Buenos Aires
  • CINME - Buenos Aires
  • Hospital Britanico Buenos Aires - Buenos Aires
  • Peking University First Hospital - Beijing
  • Sichuan Provincial People's Hospital - Chengdu
  • The 1st Affiliated hospital of Fujian Medical University - Fuzhou
  • Nanfang Hospital, Southern Medical University - Guangzhou

São Paulo

  • Hospital de Base de Sao Jose do Rio Preto - São José do Rio Preto
  • Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos - São Paulo
  • Hospital das Clinicas - FMUSP - São Paulo

California

  • Kaiser Permanente - San Francisco Medical Center - San Francisco

Colorado

  • University of Colorado in Denver-Anschutz Medical Campus - Aurora

Florida

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

Iowa

  • University of Iowa - Iowa City

Michigan

  • Henry Ford Hospital - Detroit

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2021-06-25
Est. Completion 2027-12-21
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT04629248

The ClinicalTrials.gov registry entry for NCT04629248 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 119-participant average among 8 other Primary Membranous Nephropathy trials with a reported enrollment target (19% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Primary Membranous Nephropathy appearing as the primary indexed condition, and to 5 interventions - of which Obinutuzumab is the first listed.

NCT04629248 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, São Paulo, California.

Frequently Asked Questions

What is clinical trial NCT04629248 about?

NCT04629248 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy". This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).

What is the current status of trial NCT04629248?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 142 participants. The study started on 2021-06-25. Estimated completion is 2027-12-21.

What conditions does trial NCT04629248 study?

This clinical trial studies the following conditions: Primary Membranous Nephropathy.

What interventions are being tested in trial NCT04629248?

The interventions under investigation include: Obinutuzumab (DRUG), Acetaminophen (DRUG), Methylprednisolone (DRUG), Diphenhydramine (DRUG), Tacrolimus (DRUG).

Who is sponsoring clinical trial NCT04629248?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04629248 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Iowa, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.