Completed

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

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What is being tested

adalimumab

Drug
Who is being recruted

Urogenital Diseases+9

+ Female Urogenital Diseases and Pregnancy Complications

+ Glomerulonephritis

From 6 to 80 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 2
Interventional
Study Start: October 2019
See protocol details

Summary

Principal SponsorUniversity of Michigan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 2, 2019

Actual date on which the first participant was enrolled.

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).

Official TitlePrecision Medicine Proof of Concept for Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
NCT04009668
Principal SponsorUniversity of Michigan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisGlomerulosclerosis, Focal SegmentalKidney DiseasesNephritisNephrosisNephrosis, LipoidNephrotic SyndromeUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

9 inclusion criteria required to participate
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
Show More Criteria
18 exclusion criteria prevent from participating
Severe obesity
Kidney or other solid organ or bone marrow transplant recipient
Allergy or intolerance to investigational agent
Secondary Focal Segmental Glomerulosclerosis (FSGS)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

The University of Michigan

Ann Arbor, United StatesOpen The University of Michigan in Google Maps
Suspended

New York University

New York, United States
Suspended

Levine Children's Hospital/Atrium Health

Charlotte, United States
Suspended

Cleveland Clinic Foundation

Cleveland, United States
Completed4 Study Centers
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