Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
Who is this study for? African American/Blacks with APOL1- associated focal segmental glomerulosclerosis and non-diabetic APOL1-associated chronic kidney disease due to hypertension
What treatments are being studied? Baricitinib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to determine if the drug, baricitinib, is safe and effective in reducing high levels of albumin in the urine (albuminuria) in African American/Blacks with APOL1- associated focal segmental glomerulosclerosis (FSGS) and non-diabetic APOL1-associated chronic kidney disease due to hypertension (HTN-CKD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Adults 18-70 years
• High Risk APOL1 genotype (i.e., G1G1, G2G2, or G1G2)
• FSGS diagnosed by kidney biopsy or clinically diagnosed HTN-CKD
• UACR ≥300 mg/dL
• Estimated glomerular filtration rate (eGFR) ≥26 ml/min/1.73 m2 at screening
• Stable antihypertensive regimen for ≥ 1 month prior to enrolment
• Able to provide written informed consent
Locations
United States
North Carolina
Duke Research at Pickett Road
RECRUITING
Durham
Contact Information
Primary
Maurice Smith
maurice.w.smith@duke.edu
919 613 1386
Backup
Opeyemi Olabisi, MD, PhD
opeyemi.olabisi@duke.edu
9196606987
Time Frame
Start Date: 2023-04-20
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 75
Treatments
Experimental: Baricitinib
Participants will take one pill of Baricitinib daily with their regular medications.
Placebo_comparator: Placebo
Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications.
Related Therapeutic Areas
Sponsors
Collaborators: Eli Lilly and Company, National Institute on Minority Health and Health Disparities (NIMHD)
Leads: Duke University