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Baricitinib for Chronic Kidney Disease (JUSTICE Trial)
JUSTICE Trial Summary
This trial will test if the drug baricitinib is safe and effective in reducing high levels of albumin in the urine for African Americans/Blacks with APOL1- associated FSGS and non-diabetic APOL1-associated CKD due to hypertension.
JUSTICE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowJUSTICE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 3 trial • 1307 Patients • NCT01710358JUSTICE Trial Design
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Who is running the clinical trial?
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- I am currently taking strong medications to suppress my immune system.I have had a kidney transplant.My blood pressure medication has not changed in the last month.I am between 18 and 70 years old.I have been treated with a JAK inhibitor before.I have been diagnosed with FSGS or have high blood pressure-related kidney disease.I haven't taken high doses of steroids recently.My liver tests are higher than normal due to chronic liver disease.I tested positive for hepatitis B but can start the trial after treatment.Your hemoglobin level is lower than 10 grams per deciliter.I am HIV positive.I have diabetes.I have sickle cell disease.I have had shingles symptoms within the last 3 months.I am currently fighting a serious infection.I have a high-risk APOL1 genotype.Your body has very low levels of certain types of white blood cells.Your UACR level is higher than 300 mg/dL.My kidney function test shows a rate of at least 26 ml/min.Your blood pressure is very high, with the top number (systolic) above 180 or the bottom number (diastolic) above 90, after taking three measurements.My kidney disease is identified as the tip variant of FSGS.
- Group 1: Placebo
- Group 2: Baricitinib
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are octogenarians being included in this study?
"The necessary qualifications for inclusion in this trial involve being between 18 and 70 years of age."
Are there any adverse effects associated with the usage of Baricitinib?
"With a score of 2, Baricitinib is deemed to have some evidence for safety but no clinical data affirming its efficacy."
Is this experimental therapy available to volunteers yet?
"As of this moment, the information found on clinicaltrials.gov indicates that patient recruitment for this trial is still in progress. It was first published on November 1st 2022 and has been amended as recently as September 26th 2022."
How many individuals are participating in this research experiment?
"Affirmative. Records hosted on clinicaltrials.gov confirm that this medical investigation, which was first listed on November 1st 2022 is currently recruiting patients. Approximately 75 enrollees need to be acquired from one location."
Am I eligible to join this research project?
"This trial seeks to enrol 75 members of the public that suffer from renal issues and are between 18-70 years old. To be eligible, applicants must have a High Risk APOL1 genotype (G1G1, G2G2 or G1G2), FSGS confirmed by biopsy or clinical diagnosis of HTN-CKD with UACR ≥300 mg/dL, eGFR at screening is required to exceed 30 ml/min/1.73 m2, a stable antihypertensive regimen for more than one month prior to signup and they need to provide written consent after being informed about"
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