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

Primary Purpose

Chronic Kidney Diseases

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Baricitinib

Placebo

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring APOL1, focal segmental glomerulosclerosis (FSGS)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Duke Research at Pickett RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Baricitinib

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent change in albuminuria (UACR)

Secondary Outcome Measures

Percent change in eGFR as measured by blood test

Percent change in urine CXCL 9-11 as measured by urine test

Number of adverse events as measured by patient report

Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL

Full Information

NCT ID

NCT05237388

First Posted

January 31, 2022

Last Updated

April 21, 2023

Sponsor

Duke University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05237388

Brief Title

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Acronym

JUSTICE

Official Title

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2023 (Actual)

Primary Completion Date

March 31, 2026 (Anticipated)

Study Completion Date

March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

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

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Diseases

Keywords

APOL1, focal segmental glomerulosclerosis (FSGS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Baricitinib

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Baricitinib

Intervention Description

One pill daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Baricitinib placebo pill

Primary Outcome Measure Information:

Title

Percent change in albuminuria (UACR)

Time Frame

Baseline, monthly for 6 months

Secondary Outcome Measure Information:

Title

Percent change in eGFR as measured by blood test

Time Frame

Baseline, monthly for 6 months

Title

Percent change in urine CXCL 9-11 as measured by urine test

Time Frame

Baseline, monthly for 6 months

Title

Number of adverse events as measured by patient report

Time Frame

Up to 6 months

Title

Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maurice Smith

Phone

919 613 1386

maurice.w.smith@duke.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Opeyemi Olabisi, MD, PhD

Phone

9196606987

opeyemi.olabisi@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Opeyemi Olabisi, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Research at Pickett Road

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maurice Smith

Phone

919-613-1386

maurice.w.smith@duke.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

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