NCT04009668

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

Precision Medicine Proof of Concept for Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 6 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	adalimumab	Adalimumab will be dosed based on weight

Timeline

• Start date: 2019-10-02
• Primary completion: 2023-09-05
• Completion: 2023-10-03
• First posted: 2019-07-05
• Last updated: 2024-10-30
• Results posted: 2024-10-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study