Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT04009668
Phase
PHASE2
Status
Completed

Conditions

  • FSGS
  • Focal Segmental Glomerulosclerosis
  • MCD
  • Minimal Change Disease

Eligibility Criteria

Sex
ALL
Age
6 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — DRUG
    Adalimumab will be dosed based on weight

Study Details

Adalimumab, a treatment which blocks tumor necrosis factor (TNF), was tested to see if it changed levels of urine biomarker levels, tissue inhibitor of metalloprotease-1 (TIMP1), and monocyte chemoattractant protein-1 (MCP1). Results may help develop individualized treatment options for future patients with TNF-driven focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).

Key Dates

Start date
Oct 2, 2019
Status verified
Oct 2024
Primary completion
Sep 5, 2023
Completion
Oct 3, 2023

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: adalimumab
    Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously

Primary Outcome Measure

Change in Urine MCP1/Cr Levels [ Time Frame: 10 Weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
The University of MichiganAnn ArborMichigan48109-
New York UniversityNew YorkNew York10016-
Levine Children's Hospital/Atrium HealthCharlotteNorth Carolina28207-
Cleveland Clinic FoundationClevelandOhio44195-

Find similar trials in Ann Arbor, MI

By research site
The University of Michigan· Ann Arbor, MINew York University· New York, NYLevine Children's Hospital/Atrium Health· Charlotte, NCCleveland Clinic Foundation· Cleveland, OH

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