Using baricitinib to treat kidney disease linked to APOL1 genetics
Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
This study is testing if the medication baricitinib can help reduce kidney problems in African American adults with specific genetic risks for kidney disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | adalimumab, certolizumab, golimumab, infliximab, rituximab, sarilumab, tocilizumab, ruxolitinib, tofacitinib, prednisone, baricitinib |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05237388 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of baricitinib in reducing albumin levels in the urine of African American/Blacks suffering from APOL1-associated focal segmental glomerulosclerosis (FSGS) and non-diabetic chronic kidney disease due to hypertension. Participants will be adults aged 18-70 with specific high-risk APOL1 genotypes and diagnosed kidney conditions. The study will involve a comparison between the drug and a placebo to assess its impact on kidney function and disease progression.
Who should consider this trial
Good fit: Ideal candidates are African American/Blacks aged 18-70 with high-risk APOL1 genotypes and diagnosed FSGS or hypertension-related chronic kidney disease.
Not a fit: Patients with diabetes, HIV, sickle cell disease, or those with certain severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve kidney health and reduce complications for patients with APOL1-associated kidney diseases.
How similar studies have performed: Other studies have shown promise in targeting APOL1-related kidney diseases, but this specific approach using baricitinib is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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) ≥26 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, 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.
Where this trial is running
Durham, North Carolina
- Duke Research at Pickett Road — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Opeyemi Olabisi, MD — Duke University
- Study coordinator: Maurice Smith
- Email: maurice.w.smith@duke.edu
- Phone: 919 613 1386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.