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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04009668
Other study ID # HUM00147018
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2, 2019
Est. completion date October 3, 2023

Study information

Verified date November 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The researchers are testing adalimumab, a treatment which blocks tumor necrosis factor (TNF), to see if it changes levels of urine biomarker levels (TIMP1 and MCP1). The outcomes may help develop individualized treatment options for future patients with TNF driven Focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date October 3, 2023
Est. primary completion date October 3, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
adalimumab
Adalimumab will be dosed based on weight

Locations

Country Name City State
United States The University of Michigan Ann Arbor Michigan
United States Levine Children's Hospital/Atrium Health Charlotte North Carolina
United States Cleveland Clinic Foundation Cleveland Ohio
United States New York University New York New York

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in urine MCP1/Cr levels Change measured by for enzyme-linked immunosorbent assay (ELISA) testing Baseline, Week 10
Primary Change in urine TIMP1/Cr levels Change measured by for enzyme-linked immunosorbent assay (ELISA) testing Baseline, Week 10
Secondary Incidence adverse events (AEs) Adverse events (AEs) include abnormal clinical laboratory tests and severe AEs. Through study week 14
Secondary Percent change of estimated glomerular filtration rate (eGFR) Measured by a blood sample. Summarized descriptively, including baseline, follow-up and changes from baseline. Baseline, Week 10
Secondary Percent change in Urine Protein Creatinine Ratio (UPC) Measured by a blood sample. Summarized descriptively, including baseline, follow-up and changes from baseline. Baseline, Week 10
Secondary 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 Urine specimen Week 10
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