Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT04009668
Eligibility 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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
80 Years
Study:
NCT04009668
Study Brief:
Protocol Section:
NCT04009668