Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

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).

CT.gov Identifier
NCT05237388
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Eli Lilly
Collaborator
Duke University Medical Center, National Center on Minority Health and Health Disparities
Study Contact Information
+1 317 276 2000
Recruiting
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Study Details

Diseases
APOL1 Mediated Kidney Disease (AMKD)
Focal Segmental Glomerulosclerosis
Study Drug
Baricitinib
Genes
APOL1
Study Dates
Apr 2023 - Mar 2026
Sex
Female & Male
Age
18 - 70 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • 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 Criteria:
  • 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.

Protocol Summary

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).

Study Locations

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