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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT04009668
• Date of registration: 02/07/2019
• Prospective Registration: Yes
• Primary sponsor: University of Michigan
• Public title: Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
• Scientific title: Precision Medicine Proof of Concept for Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
• Date of first enrolment: October 2, 2019
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04009668
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Zubin Modi, MD
• Affiliation: University of Michigan

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

MCD

FSGS

Focal Segmental Glomerulosclerosis

Minimal Change Disease

Intervention(s)

Drug: adalimumab

Primary Outcome(s)

Change in urine TIMP1/Cr levels [Time Frame: Baseline, Week 10]

Change in urine MCP1/Cr levels [Time Frame: Baseline, Week 10]

Secondary Outcome(s)

Proportion of participants achieving a nadir Urine Protein Creatinine Ratio (UPC) less than 1.5 g/g and at least a 40% reduction from baseline [Time Frame: Week 10]

Incidence adverse events (AEs) [Time Frame: Through study week 14]

Percent change in Urine Protein Creatinine Ratio (UPC) [Time Frame: Baseline, Week 10]

Percent change of estimated glomerular filtration rate (eGFR) [Time Frame: Baseline, Week 10]

Secondary ID(s)

HUM00147018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors