Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
NCT ID: NCT05237388
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2023-04-20
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Baricitinib
Participants will take one pill of Baricitinib daily with their regular medications.
Baricitinib
One pill daily
Placebo
Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications.
Placebo
Baricitinib placebo pill
Interventions
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Baricitinib
One pill daily
Placebo
Baricitinib placebo pill
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Eli Lilly and Company
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Opeyemi Olabisi, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Research at Pickett Road
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00108755
Identifier Type: -
Identifier Source: org_study_id
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