| Trial ID: | L0041 |
| Source ID: | NCT05237388
|
| Associated Drug: |
Baricitinib
|
| Title: |
Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
|
| Acronym: |
JUSTICE
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases
|
| Interventions: |
DRUG: Baricitinib|DRUG: Placebo
|
| Outcome Measures: |
Primary: Percent change in albuminuria (UACR), Baseline, monthly for 6 months | Secondary: 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
|
| Sponsor/Collaborators: |
Sponsor: Duke University | Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)|Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
75
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-04-20
|
| Completion Date: |
2026-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-18
|
| Locations: |
Duke Research at Pickett Road, Durham, North Carolina, 27705, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05237388
|
