Chronic Kidney DiseasesPhase 2JUSTICENCT05237388
Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
A Phase 2 study testing Baricitinib in people with Chronic Kidney Diseases, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 3 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Research at Pickett Road
Durham, North Carolina, 27705
About this study
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).
- Conditions
- Chronic Kidney Diseases
- Being tested
- Baricitinib, Placebo
- Keywords
- APOL1, focal segmental glomerulosclerosis (FSGS)
- Medical subject headings
- Renal Insufficiency, Chronic, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
One pill daily
PlaceboDrug
Baricitinib placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Participants will take one pill of Baricitinib daily with their regular medications. Receives: Drug: Baricitinib |
| Placebo | Placebo comparator | Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in albuminuria (UACR)
Measured: Baseline, monthly for 6 months
Secondary outcomes (4)
Percent change in eGFR as measured by blood test
Measured: Baseline, monthly for 6 months
Percent change in urine CXCL 9-11 as measured by urine test
Measured: Baseline, monthly for 6 months
Number of adverse events as measured by patient report
Measured: Up to 6 months
Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start20 Apr 2023
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Opeyemi Olabisi, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237388
- Sponsor's protocol ID
- Pro00108755
- Other IDs
- R01MD016401-01
- Acronym
- JUSTICE
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barrett N, Odera JO, Bethea K, Smith M, Sadeghpour A, Matthews L, Lucas A, Godbee RL, Dowdy O, Miles L, Olabisi OA; CARE Community Partners. Hybrid Community-Electronic Health Record Approaches to Apolipoprotein L1 Kidney Disease Screening and Clinical Trials among Black Individuals. J Am Soc Nephrol. 2026 Aug 1;37(8):1720-1732. doi: 10.1681/ASN.0000001062. Epub 2026 Mar 3.
PubMed 41774497Shen CL, Richardson A, Martin-Fernandez M, Malle L, Buta S, Patel A, Rosberger H, Lim J, Horesh M, Saland J, Bogunovic D. Cytokine-Driven Janus Kinase Signal Transducer and Activator of Transcription Pathway Hyperactivity Predicts Disease Severity in Pediatric FSGS. Kidney360. 2026 Feb 1;7(2):260-268. doi: 10.34067/KID.0000001010. Epub 2025 Nov 14.
PubMed 41236849
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
- ClinicalTrials.gov ID
- NCT05237388
- Acronym / sponsor ID
- JUSTICE / Pro00108755
- Conditions
- Chronic Kidney Diseases
- Keywords
- APOL1, focal segmental glomerulosclerosis (FSGS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Eli Lilly and Company
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: BaricitinibParticipants will take one pill of Baricitinib daily with their regular medications. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- Diabetes
- HIV
- Sickle cell disease.
- Tip variant of FSGS.
- Systolic BP >180 mmHg or diastolic BP >90 mmHg based on average of 3 measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibOne pill daily | Drug | Baricitinib |
| PlaceboBaricitinib placebo pill | Drug | Placebo |
Primary outcome
Percent change in albuminuria (UACR)
Time frame: Baseline, monthly for 6 months
4 secondary outcomes
Percent change in eGFR as measured by blood test
Time frame: Baseline, monthly for 6 months
Percent change in urine CXCL 9-11 as measured by urine test
Time frame: Baseline, monthly for 6 months
Number of adverse events as measured by patient report
Time frame: Up to 6 months
Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 41774497Barrett N, Odera JO, Bethea K, Smith M, Sadeghpour A, Matthews L, Lucas A, Godbee RL, Dowdy O, Miles L, Olabisi OA; CARE Community Partners. Hybrid Community-Electronic Health Record Approaches to Apolipoprotein L1 Kidney Disease Screening and Clinical Trials among Black Individuals. J Am Soc Nephrol. 2026 Aug 1;37(8):1720-1732. doi: 10.1681/ASN.0000001062. Epub 2026 Mar 3.
- Derived from this study: PubMed 41236849Shen CL, Richardson A, Martin-Fernandez M, Malle L, Buta S, Patel A, Rosberger H, Lim J, Horesh M, Saland J, Bogunovic D. Cytokine-Driven Janus Kinase Signal Transducer and Activator of Transcription Pathway Hyperactivity Predicts Disease Severity in Pediatric FSGS. Kidney360. 2026 Feb 1;7(2):260-268. doi: 10.34067/KID.0000001010. Epub 2025 Nov 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Opeyemi Olabisi, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib in people with Chronic Kidney Diseases, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in albuminuria (UACR) (time frame: Baseline, monthly for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237388, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.