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Immunosuppressant
Belatacept for Immunosuppression in Kidney Transplant Recipients
Phase 4
Recruiting
Led By Cyrus Feizpour, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after the start of immunosuppression wean
Awards & highlights
Study Summary
This trial is testing if a patient's DNA can predict if they will have a successful kidney transplant with just one immunosuppressive drug, instead of the multiple drugs typically required.
Who is the study for?
This trial is for adult kidney transplant recipients who have had their new organ for at least 9 months, are on Belatacept or can switch to it, and have stable kidney function. It's not for those with severe liver issues, recent acute rejection episodes, multiple transplants, pregnancy plans during the trial, or current participation in other drug trials.Check my eligibility
What is being tested?
The study tests if DNA markers can help transition patients from multiple immunosuppressant drugs to just Belatacept. Researchers will see if donor-derived cell-free DNA (AlloSure) and gene expression (AlloMap) predict how well a patient's immune system tolerates this change.See study design
What are the potential side effects?
Belatacept may cause side effects like increased risk of infections due to suppressed immunity. There might also be reactions related to infusion of the medication and potential impacts on liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after the date of the first immunosuppression taper
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after the date of the first immunosuppression taper
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with acute kidney graft rejection
Secondary outcome measures
Mean change in Estimated Glomerular Filtration Rate (eGFR)
Mean prediction score of allograft loss as measured by iBox
Negative predictable value as measured by AlloMap®
+4 moreSide effects data
From 2016 Phase 4 trial • 3 Patients • NCT0207819367%
COPD exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept
Trial Design
1Treatment groups
Experimental Treatment
Group I: Immunosuppression TaperExperimental Treatment1 Intervention
Patients included in this arm are kidney transplant recipients with stable kidney function currently on or are converting to a Belatacept based immunosuppression regimen. Eligible patients who are deemed immune quiescent after a 3 month monitoring period will undergo sequential withdrawal of immunosuppression medications over a 12 month period from a three drug regimen to a Belatacept only immunosuppression regimen. During the total 15 month period patients will be monitored with monthly clinic visits, blood draws for routine monitoring as well as donor derived cell free DNA and genetic testing through KidneyCare to monitor immune suppression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belatacept
2013
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,057 Previous Clinical Trials
1,055,051 Total Patients Enrolled
CareDxIndustry Sponsor
25 Previous Clinical Trials
15,457 Total Patients Enrolled
4 Trials studying Immunosuppression
997 Patients Enrolled for Immunosuppression
Cyrus Feizpour, MDPrincipal InvestigatorUT Southwestern Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My current kidney transplant is affected by BK virus.I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.I've been on Belatacept for my kidney with stable function for 3 months.I have severe liver problems.My organ transplant is from a non-identical donor.My kidney function has been stable for the last 3 months.I have had a kidney transplant in both of my kidneys.My body does not have specific antigens against a donor.I am over 18 and have received a kidney transplant.I had a kidney transplant more than 9 months ago.I have had severe or frequent rejection episodes in the last 3 months.I have had an organ transplant that is not a kidney.
Research Study Groups:
This trial has the following groups:- Group 1: Immunosuppression Taper
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- 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.
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