Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Duke University
With
National Institute on Minority Health and Health Disparities (NIMHD)
Eli Lilly and Company
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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.
Clareo Health | Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease