All > Kidney Failure

Baricitinib for Chronic Kidney Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Duke Research at Pickett Road, Durham, NCChronic Kidney DiseaseBaricitinib - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Chronic Kidney Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Baricitinib
1
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BI 764198

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 6 months

Month 6
Percent change in albuminuria (UACR)
Percent change in eGFR as measured by blood test
Percent change in urine CXCL 9-11 as measured by urine test
Up to 6 months
Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL
Number of adverse events as measured by patient report

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
Baricitinib
2
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2
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Side Effects for

Adalimumab Treatment B
5%Nasopharyngitis
3%Pharyngitis
2%Urinary tract infection
2%Bronchitis
1%Back pain
1%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01710358) in the Adalimumab Treatment B ARM group. Side effects include: Nasopharyngitis with 5%, Pharyngitis with 3%, Urinary tract infection with 2%, Bronchitis with 2%, Back pain with 1%.

Trial Design

2 Treatment Groups

Baricitinib
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

75 Total Participants · 2 Treatment Groups

Primary Treatment: Baricitinib · Has Placebo Group · Phase 2

Baricitinib
Drug
Experimental Group · 1 Intervention: Baricitinib · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2020
Completed Phase 3
~10920

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH
303 Previous Clinical Trials
1,284,388 Total Patients Enrolled
Duke UniversityLead Sponsor
2,209 Previous Clinical Trials
3,221,221 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,481 Previous Clinical Trials
3,143,023 Total Patients Enrolled
Opeyemi Olabisi, MDPrincipal InvestigatorDuke University

Eligibility Criteria

Age 18 - 70 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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