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Currently Enrolling
Interventional

CARE and JUSTICE

JUSTICE Clinical Trial Janus kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease (JUSTICE)

JUSTICE is a single-center, double-blinded, randomized trial of baricitinib therapy for APOL1-associated FSGS or Hypertension Associated-CKD.

Trial Physician / Study Coordinator

Maurice Smith

Email Phone
Site Name

Duke University
300 North Duke Street, Durham, NC 27701

Find other locations for this trial:
Currently Enrolling
Interventional

CARE and JUSTICE

JUSTICE Clinical Trial Janus kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease (JUSTICE)

JUSTICE is a single-center, double-blinded, randomized trial of baricitinib therapy for APOL1-associated FSGS or Hypertension Associated-CKD.

Eligibility Criteria
Patient Population

Focal Segmental Glomerulosclerosis or clinically diagnosed HTN-CKD

Age

18 — 26+

History of transplant allowed?

No

History of dialysis allowed?

No

eGFR

15 — > 60

UPCR

3.0 or Above

Permitted medication history

Ace Inhibitors/ARB, Prednisone (Steroids), Other, None

Patient should be

Treatment Resistant, Neither of These

About the Drug
What is involved for the patient

Participants will be randomized to receive baricitinib or placebo control. Urine and a small blood sample will be collected monthly to monitor kidney function. Participants will be followed for 6 months. Participants will receive compensation each month.

Sponsor

NIAHD

Estimated End Date

2026

About the Trial
Study Drug

Baricitinib

Study Goal

The goal of JUSTICE clinical trial is to determine whether inhibition of APOL1 protein production by baricitinib would slow down progression of APOL1-mediated kidney disease and reduce spillage of protein in the urine.

Find other locations for this trial:
Durham, NC
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

See other frequently asked questions