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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05237388
Recruitment Status : Not yet recruiting
First Posted : February 14, 2022
Last Update Posted : July 18, 2022
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Eli Lilly and Company
Information provided by (Responsible Party):
Duke University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 30, 2022
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Baricitinib

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percent change in albuminuria (UACR) [ Time Frame: Baseline, monthly for 6 months ]

Secondary Outcome Measures :
  1. Percent change in eGFR as measured by blood test [ Time Frame: Baseline, monthly for 6 months ]
  2. Percent change in urine CXCL 9-11 as measured by urine test [ Time Frame: Baseline, monthly for 6 months ]
  3. Number of adverse events as measured by patient report [ Time Frame: Up to 6 months ]
  4. Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL [ Time Frame: Up to 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05237388


Contacts
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Contact: Jackie Jordan 919 613 1235 jackie.jordan-lee@duke.edu
Contact: Opeyemi Olabisi, MD, PhD 9196606987 opeyemi.olabisi@duke.edu

Locations
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United States, North Carolina
Duke Research at Pickett Road
Durham, North Carolina, United States, 27705
Contact: Jackie Jordan    919-613-1235    jackie.jordan-lee@duke.edu   
Sponsors and Collaborators
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)
Eli Lilly and Company
Investigators
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Principal Investigator: Opeyemi Olabisi, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05237388    
Other Study ID Numbers: Pro00108755
R01MD016401-01 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
APOL1
focal segmental glomerulosclerosis (FSGS)
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency