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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-02

Study Completion Date

2023-10-03

Brief Summary

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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).

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Detailed Description

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Conditions

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FSGS MCD Focal Segmental Glomerulosclerosis Minimal Change Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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adalimumab

Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously

Group Type EXPERIMENTAL

adalimumab

Intervention Type DRUG

Adalimumab will be dosed based on weight

Interventions

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adalimumab

Adalimumab will be dosed based on weight

Intervention Type DRUG

Other Intervention Names

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Humira

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No