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).

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
• 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

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

This trial will follow the publication and data sharing policies of the NEPTUNE study, www.NEPTUNE-study.org

Request for ancillary studies should be submitted through the project contact and will be reviewed by the project steering committee.

After the study is completed, data will be submitted to the Nephrotic Syndrome Study Network (NEPTUNE), an NIH funded consortium. Proposals to access the data will then be submitted via the NEPTUNE Ancillary Studies program (NEPTUNE-study.org). Following closure of NEPTUNE, the trial data will convey with the NEPTUNE date to the NIH/NIDDK repository and can be accessed through this mechanism following approval.

At the latest, data will be shared with the NEPTUNE Data Analysis and Coordinating Center at the time of publication of final results or 24 months after transfer of samples or raw data sets.

While this study is open data requests from this study will need to seek approval from the trial steering committee.

Once the data is transferred to the NEPTUNE study, all study data will become part of the aggregate NEPTUNE data and available to NEPTUNE participant sites and other requesting third parties upon request. Subsequent access to these data will be governed by the NIH Office of Rare Diseases (ORD) data sharing policies.