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NCT03949855 · ClinicalTrials.gov registry record · Phase 2

Belimumab With Rituximab for Primary Membranous Nephropathy

A Phase 2 study of Nephrotic Syndrome and Membranous Nephropathy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Recruiting
Registry status
Phase 2
Development phase
58
Enrollment target
20
Study locations

NCT03949855 is a Phase 2 study of Nephrotic Syndrome and Membranous Nephropathy that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 58 participants, below the 639-participant average among 7 other Nephrotic Syndrome trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT03949855, a Phase 2 study of Nephrotic Syndrome and Membranous Nephropathy, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
Phase 2
Development phase
58 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy. Background: Primary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life. Primary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine. Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects. In this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again. Belimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat

Conditions Studied

Nephrotic Syndrome Membranous Nephropathy

Interventions

  • DRUG Rituximab
  • DRUG Belimumab
  • DRUG Placebo for Belimumab

Study Locations (20)

California

  • University of California San Francisco - San Francisco
  • Stanford University School of Medicine: Division of Nephrology - Stanford
  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:Division of Nephrology and Hypertension - Torrance

Florida

  • Mayo Clinic Jacksonville: Department of Nephrology and Hypertension - Jacksonville
  • University of Miami Miller School of Medicine, Div of Nephrology - Miami

Maryland

  • Johns Hopkins - Baltimore
  • National Institutes of Health Clinical Center - Bethesda

Ohio

  • Cleveland Clinic - Cleveland
  • Ohio State University Wexner Medical Center: Division of Nephrology - Columbus

Alabama

  • University of Alabama at Birmingham School of Medicine: Division of Nephrology - Birmingham

Arkansas

  • University of Arkansas - Little Rock

Colorado

  • University of Colorado - Aurora

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2020-03-06
Est. Completion 2030-03-01
Phase Phase 2

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03949855

The ClinicalTrials.gov registry entry for NCT03949855 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 639-participant average among 7 other Nephrotic Syndrome trials with a reported enrollment target (91% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Nephrotic Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.

NCT03949855 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT03949855 about?

NCT03949855 is a clinical study titled "Belimumab With Rituximab for Primary Membranous Nephropathy". The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy. Background: Primary membranous nephr...

What is the current status of trial NCT03949855?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-03-06. Estimated completion is 2030-03-01.

What conditions does trial NCT03949855 study?

This clinical trial studies the following conditions: Nephrotic Syndrome, Membranous Nephropathy.

What interventions are being tested in trial NCT03949855?

The interventions under investigation include: Rituximab (DRUG), Belimumab (DRUG), Placebo for Belimumab (DRUG).

Who is sponsoring clinical trial NCT03949855?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03949855 being conducted?

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

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