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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The researchers are testing adalimumab, a treatment which blocks tumor necrosis factor (TNF), to see if it changes levels of urine biomarker levels (TIMP1 and MCP1). The outcomes may help develop individualized treatment options for future patients with TNF driven Focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: New York University
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Kidney biopsy confirmed Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

• For Minimal Change Disease patients only, history of resistance to corticosteroid therapy

• Qualifying archived biopsy tissue is available for testing of gene expression profiling

• Increased urinary excretion of biomarkers of Tumor Necrosis Factor (TNF) activation (MCP1/Cr and/ or TIMP1/Cr) at study screening

• eGFR>45 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

Exclusion Criteria:

• 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