Chronic Kidney Diseases
Conditions
Keywords
APOL1, focal segmental glomerulosclerosis (FSGS)
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- associated focal segmental glomerulosclerosis (FSGS) and non-diabetic APOL1-associated chronic kidney disease due to hypertension (HTN-CKD).
Interventions
DRUGBaricitinib
One pill daily
DRUGPlacebo
Baricitinib placebo pill
Sponsors
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in albuminuria (UACR) | Baseline, monthly for 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in eGFR as measured by blood test | Baseline, monthly for 6 months |
| Percent change in urine CXCL 9-11 as measured by urine test | Baseline, monthly for 6 months |
| Number of adverse events as measured by patient report | Up to 6 months |
| Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL | Up to 6 months |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROpeyemi Olabisi, MD
Duke University
Outcome results
None listed