Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

NCT05237388 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: Pro00108755R01MD016401-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Diseases

Keywords

APOL1; focal segmental glomerulosclerosis (FSGS)

Outcome Measures

Primary Outcomes (1)

• Percent change in albuminuria (UACR)

  Baseline, monthly for 6 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Baricitinib

EXPERIMENTAL

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

Drug: Baricitinib

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Baricitinib DRUG

One pill daily

Baricitinib

Placebo DRUG

Baricitinib placebo pill

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, etanercept, golimumab, infliximab, probenecid, rituximab, ruxolitinib, sarilumab, tofacitinib, or tocilizumab.

Sponsors & Collaborators

• Duke University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Duke Research at Pickett Road

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• 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.

  PMID: 41774497 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.

  PMID: 41236849 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Glomerulosclerosis, Focal Segmental

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glomerulonephritis; Nephritis

Study Officials

• Opeyemi Olabisi, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 14, 2022
• Study Start: April 20, 2023
• Primary Completion: April 3, 2026
• Study Completion: April 3, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)