RECRUITING

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Conditions

Chronic Kidney Diseases APOL1 focal segmental glomerulosclerosis (FSGS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Quick Facts

Study Start:2023-04-20

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05237388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Maurice Smith

CONTACT

919 613 1386

maurice.w.smith@duke.edu

Opeyemi Olabisi, MD, PhD

CONTACT

9196606987

opeyemi.olabisi@duke.edu

Principal Investigator

Opeyemi Olabisi, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke Research at Pickett Road

Durham, North Carolina, 27705

United States

Collaborators and Investigators

Sponsor: Duke University

Opeyemi Olabisi, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-20

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-04-20

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

APOL1
focal segmental glomerulosclerosis (FSGS)

Additional Relevant MeSH Terms

Chronic Kidney Diseases