Status:
COMPLETED
Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
Lead Sponsor:
University of Michigan
Conditions:
FSGS
MCD
Eligibility:
All Genders
6-80 years
Phase:
PHASE2
Brief Summary
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 chemoatt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04009668
Start Date
October 2 2019
End Date
October 3 2023
Last Update
October 30 2024
Active Locations (4)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109
2
New York University
New York, New York, United States, 10016
3
Levine Children's Hospital/Atrium Health
Charlotte, North Carolina, United States, 28207
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195