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

Completed · Phase 2

Conditions studied: FSGS, MCD, Focal Segmental Glomerulosclerosis, Minimal Change Disease

In brief

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 facts

Study ID

NCT04009668

Run by

University of Michigan

People needed

7

Starts

2019-10-02

Expected to finish

2023-10-03

Last updated by the study team

2024-10-30

Who can join

Age: 6 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Kidney biopsy confirmed Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
• For Minimal Change Disease patients only, history of resistance to corticosteroid therapy
• Increased urinary excretion of biomarkers of Tumor Necrosis Factor (TNF) activation (MCP1/Cr and/ or TIMP1/Cr) at study screening
• eGFR>30 ml/min/1.73 m2 at screening
• Urine protein:creatinine ratio ≥1.5 g/g at screening
• Weight >15 kg
• Stable therapy with angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and oral immunosuppression agents for at least 30 days prior to enrollment
• Birth control use in females of child bearing potential
• Informed consent and assent if applicable

You may not qualify if…

• Kidney or other solid organ or bone marrow transplant recipient
• Allergy or intolerance to investigational agent
• Secondary Focal Segmental Glomerulosclerosis (FSGS)
• Severe obesity
• Live virus vaccine in the past 3 months
• Malignancy, current or in the past 5 years
• Active local or systemic bacterial, fungal or viral infection
• Active or latent Hepatitis B, Hepatitis C, HIV, or tuberculosis
• History of demyelinating disease, e.g. Multiple Sclerosis or Guillain-Barre
• History of heart failure
• Active liver disease
• Systemic lupus erythematosus or ANA > 1:80
• History of inflammatory bowel disease, e.g. ulcerative colitis or Crohns disease
• Cyclophosphamide in past 90 days, Rituximab in the past 180 days
• Pregnancy or nursing
• Blood white blood cell count <4,500/mm3; Hg <9 g/dL; Platelet count <150,000/mm3 at enrollment. - Use of an erythropoiesis stimulating agent will not be an exclusion criterion.
• Concurrent use of interleukin-1 antagonist (Anakinra), other TNF blocking agent, methotrexate or abatacept
• Diabetes Mellitus

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States
• New York University — New York, New York, United States
• Levine Children's Hospital/Atrium Health — Charlotte, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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