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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD016401-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Eli Lilly and Company | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Participants will take one pill of Baricitinib daily with their regular medications. |
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| Placebo | Placebo Comparator | Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | One pill daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in albuminuria (UACR) | Baseline, monthly for 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Opeyemi Olabisi, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Research at Pickett Road | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41774497 | Derived | 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 Mar 3. doi: 10.1681/ASN.0000001062. Online ahead of print. | |
| 41236849 | Derived | Shen 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 30, 2025 | Apr 20, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D005923 | Glomerulosclerosis, Focal Segmental |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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| Drug |
Baricitinib placebo pill |
|
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |