← Back to Search

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

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after the date of the first immunosuppression taper for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with acute kidney graft rejection

Secondary study objectives

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 more

Side effects data

From 2016 Phase 4 trial • 3 Patients • NCT02078193

67%

COPD exacerbation

100%

80%

60%

40%

20%

Study treatment Arm

Belatacept

Awards & Highlights

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.

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

Do I qualify?Apply below to find out