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TNF Inhibitor

adalimumab for Focal Segmental Glomerulosclerosis

Phase 2
Waitlist Available
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study week 14
Awards & highlights

Study Summary

This trial is testing a new treatment to see if it changes urine biomarker levels. The outcomes may help develop individualized treatment options for future patients with a certain kidney disease.

Eligible Conditions
  • Focal Segmental Glomerulosclerosis
  • Microcephaly-Capillary Malformation Syndrome
  • Nephrotic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in urine MCP1/Cr levels
Change in urine TIMP1/Cr levels
Secondary outcome measures
Incidence adverse events (AEs)
Percent change in Urine Protein Creatinine Ratio (UPC)
Percent change of estimated glomerular filtration rate (eGFR)
+1 more

Side effects data

From 2020 Phase 4 trial • 4372 Patients • NCT02092467
22%
Upper respiratory tract infection
15%
Bronchitis
13%
Rheumatoid arthritis
13%
Urinary tract infection
12%
Nasopharyngitis
12%
Fall
12%
Herpes zoster
9%
Hypertension
8%
Arthralgia
7%
Diarrhoea
7%
Lymphopenia
7%
Sinusitis
7%
Back pain
6%
Osteoarthritis
6%
Influenza
6%
Latent tuberculosis
6%
Pharyngitis
5%
Nausea
5%
Anaemia
5%
Alanine aminotransferase increased
5%
Cough
4%
Gastroenteritis
3%
Pneumonia
3%
Headache
1%
Femur fracture
1%
Coronary artery disease
1%
Cellulitis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID
TNFi

Trial Design

1Treatment groups
Experimental Treatment
Group I: adalimumabExperimental Treatment1 Intervention
Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
adalimumab
2005
Completed Phase 4
~12370

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,782 Previous Clinical Trials
6,364,650 Total Patients Enrolled
Debbie Gipson, MS, MDStudy DirectorUniversity of Michigan
Debbie S. Gipson, MS, MDStudy DirectorUniversity of Michigan

Media Library

Adalimumab (TNF Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04009668 — Phase 2
Focal Segmental Glomerulosclerosis Research Study Groups: adalimumab
Focal Segmental Glomerulosclerosis Clinical Trial 2023: Adalimumab Highlights & Side Effects. Trial Name: NCT04009668 — Phase 2
Adalimumab (TNF Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04009668 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently enrolled in this research endeavor?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study is presently recruiting participants in 4 different locations with a goal of 8 enrollees. The trial was first published October 2nd 2019 and last edited July 22nd 2022."

Answered by AI

Do I meet the qualifications to register for this medical trial?

"Patients with nephrotic syndrome between 6 and 70 years of age may be eligible to join this clinical trial. It is currently looking for 8 participants in total."

Answered by AI

Is eligibility for this trial restricted to those over 18 years of age?

"This trial has a narrow age range of between 6 to 70. However, there are numerous other studies tailored for children and the elderly; 46 for those below 18 and 127 specifically designed with seniors in mind."

Answered by AI

To what extent is adalimumab a risk to human health?

"There is evidence that adalimumab presents some degree of safety, thus our team appraised its risk level at a 2. This evaluation was based on the fact that this drug has only been evaluated in Phase 2 trials and no efficacy data exists yet."

Answered by AI

How many healthcare facilities are presently conducting this research study?

"The University of Michigan in Ann Arbor, the Cleveland Clinic Foundation in Ohio and Levine Children's Hospital/Atrium Health in Charlotte are some of the many trial sites participating."

Answered by AI

What other trials have yielded information about the effects of adalimumab?

"Currently, 50 separate clinical trials involving adalimumab are active with 14 of them in the third phase. Most of these studies originate from London but there are 2044 sites worldwide researching this medication."

Answered by AI

What are the fundamental aims of this investigation?

"The primary evaluation criteria of this clinical trial, assessed between the initial study date and Week 10, is to measure alterations in urine TIMP1/Cr concentrations. Secondary objectives involve recording any adverse events (AEs) that occur during the course of treatment; assessing patients' nadir Urine Protein Creatinine Ratio (UPC); and calculating participants' estimated glomerular filtration rate (eGFR). Descriptively summarizing these results will include baseline data as well as follow-up information detailing changes from first measurements."

Answered by AI

Is this clinical trial still accepting participants?

"Affirmative. The clinicaltrials.gov registry reveals that this research is currently recruiting participants, with the original listing posted on October 2nd 2019 and updated as recently as July 22nd 2022. Altogether, 8 individuals will be admitted across 4 sites for participation in this trial."

Answered by AI

How is adalimumab commonly employed to address various illnesses?

"Adalimumab is regularly employed to address ankylosing spondylitis, as well as various other ailments such as rheumatoid arthritis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis."

Answered by AI
~1 spots leftby Mar 2025