JUSTICE: Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Sponsor

Duke University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05237388

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH), Eli Lilly and Company (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Drug: Baricitinib Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Anticipated Study Start Date :

Jul 30, 2022

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Baricitinib Participants will take one pill of Baricitinib daily with their regular medications.	Drug: Baricitinib One pill daily
Placebo Comparator: Placebo Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications.	Drug: Placebo Baricitinib placebo pill

Arm

Intervention/Treatment

Experimental: Baricitinib

Participants will take one pill of Baricitinib daily with their regular medications.

Drug: Baricitinib

One pill daily

Placebo Comparator: Placebo

Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications.

Drug: Placebo

Baricitinib placebo pill

Outcome Measures

Primary Outcome Measures

Percent change in albuminuria (UACR) [Baseline, monthly for 6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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) ≥30 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, cyclosporine, 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Research at Pickett Road	Durham	North Carolina	United States	27705

Sponsors and Collaborators

Duke University
National Institute on Minority Health and Health Disparities (NIMHD)
Eli Lilly and Company

Investigators

Principal Investigator: Opeyemi Olabisi, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT05237388

Other Study ID Numbers:

Pro00108755
R01MD016401-01

First Posted:

Feb 14, 2022

Last Update Posted:

Jul 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Duke University

APOL1

focal segmental glomerulosclerosis (FSGS)

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Jul 18, 2022