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

  • STATUS
    Recruiting
  • End date
    Jan 11, 2022
  • participants needed
    8
  • sponsor
    University of Michigan
Updated on 11 August 2021
adalimumab
ace inhibitor
steroid therapy
tumor necrosis factor
angiotensin
immunosuppression
total protein
enzyme inhibitor
angiotensin converting enzyme
kidney biopsy
steroid treatment
biopsy tissue
minimal change disease
angiotensin-converting enzyme
focal segmental glomerulosclerosis

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).

Details
Condition Focal glomerulosclerosis, Glomerulonephritis, Lipoid nephrosis, Focal Segmental Glomerulosclerosis, MCD, minimal change disease
Treatment Adalimumab
Clinical Study IdentifierNCT04009668
SponsorUniversity of Michigan
Last Modified on11 August 2021

Eligibility

Yes No Not Sure

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
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