Status:
RECRUITING
Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Eli Lilly and Company
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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- associate...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Diabetes
- HIV
- Sickle cell disease.
- Tip variant of FSGS.
- Systolic BP \>180 mmHg or diastolic BP \>90 mmHg based on average of 3 measurements.
- Active serious viral, bacterial, fungal or parasitic infection.
- Symptomatic herpes zoster infection within 12 weeks prior to study entry.
- Positive hepatitis B surface antigen during screening (could enroll after treatment).
- Previous kidney transplant.
- History of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
- Hemoglobin \<10 g/dL.
- Absolute lymphocyte count (ALC)\<500cells/mm3 or absolute neutrophil count (ANC) \< 1000 cells/mm3.
- Pregnant or nursing at time of enrollment
- Prior or current treatment with JAK inhibitor.
- Current use of potent immunosuppressants such as abatacept, adalimumab, anakinra, azathioprine, certolizumab, etanercept, golimumab, infliximab, probenecid, rituximab, ruxolitinib, sarilumab, tofacitinib, or tocilizumab.
- High dose corticosteroids (\>10 mg per day of prednisone or equivalent) or an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization.
Key Trial Info
Start Date :
April 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05237388
Start Date
April 20 2023
End Date
March 31 2026
Last Update
March 18 2025
Active Locations (1)
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1
Duke Research at Pickett Road
Durham, North Carolina, United States, 27705