159 Participants NeededMy employer runs this trial

Inebilizumab for Membranous Glomerulonephritis

(MOMENT Trial)

Recruiting at 3 trial locations
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Amgen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this study to evaluate the efficacy of inebilizumab on primary membranous nephropathy (PMN) disease activity as measured by complete remission in participants with PMN.

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with primary membranous nephropathy, a kidney disease. People with lupus-related kidney problems or other major health issues may not be eligible.

Inclusion Criteria

I have been taking the highest dose of an ACE inhibitor or ARB for at least 3 months and my blood pressure is under 140/90.
I am between 18 and 79 years old.
Able and willing to provide written informed consent
See 3 more

Exclusion Criteria

My kidney disease is caused by another illness, infection, cancer, or medication.
I do not have any active serious infections or immune system disorders.
Clinically significant laboratory abnormalities including severe anemia, neutropenia, thrombocytopenia, low CD19+ B-cell count, hepatic dysfunction, or IgG <400 mg/dL
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Inebilizumab
  • Tacrolimus

Trial Overview

The study compares the effectiveness of inebilizumab, an experimental drug, to tacrolimus (a standard treatment) in helping people with primary membranous nephropathy achieve remission. Participants are randomly assigned to one of the treatments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: InebilizumabExperimental Treatment1 Intervention
Group II: TacrolimusActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London