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Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Precision Medicine Proof of Concept for Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease

NCT04009668•University of Michigan

View on ClinicalTrials.gov

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 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).

Eligibility

Age

6 - 80 years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (4)

The University of Michigan

Ann Arbor, Michigan, United States

New York University

New York, New York, United States

Levine Children's Hospital/Atrium Health

Charlotte, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Key Dates

Start Date

October 2, 2019

Primary Completion Date

September 5, 2023

Completion Date

October 3, 2023

Last Updated

October 30, 2024

Enrollment

ACTUAL participants

Conditions

FSGSMCDFocal Segmental GlomerulosclerosisMinimal Change Disease

Interventions

adalimumab

DRUG

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RECRUITINGPHASE1

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RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)

A Study to Evaluate the Safety, Tolerability and PK of SK-09

AMPK-activation by Metformin in FSGS: AMP-FSGS

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children

Study of WAL0921 in Patients With Glomerular Kidney Diseases