Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Phase 2

Recruiting

• Conditions: Chronic Kidney Diseases
• Interventions: Drug: Placebo; Drug: Baricitinib

• Registration Number: NCT05237388
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-14
• Study Start: 2023-04-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications.
Baricitinib	Baricitinib	Participants will take one pill of Baricitinib daily with their regular medications.

Primary Outcome Measures

Name	Time	Method
Percent change in albuminuria (UACR)	Baseline, monthly for 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke Research at Pickett Road; 🇺🇸 Durham, North Carolina, United States