← Back to Search

Checkpoint Inhibitor

Belatacept for Heart Transplant

Phase 2

Recruiting

Led By Marlena Habal, MD

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study entry: Recipient of a primary heart transplant (heart transplant only)

Randomization: No desensitization therapy prior to transplant

Must not have

Randomization: Recipient of multiple solid organ or tissue transplants

Study entry: Prior history of any organ, tissue, or cellular transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 18 months post-transplantation, assessed at baseline, month 1, 12 and 18

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the safety and effectiveness of using a medication called NULOJIX® (belatacept) in heart transplant recipients. The study will compare two different treatment regimens, one

Who is the study for?

This trial is for primary heart transplant recipients. Participants must be eligible for a heart transplant and fit to undergo the procedure. Specific inclusion or exclusion criteria are not listed, but typically these would exclude individuals with certain medical conditions or those taking conflicting medications.

What is being tested?

The study compares standard tacrolimus-based immunosuppression with a belatacept-based regimen where tacrolimus is gradually withdrawn over 9 months post-transplant. Both groups will also receive mycophenolate mofetil/sodium and corticosteroids.

What are the potential side effects?

Potential side effects may include increased risk of infection due to immune suppression, possible kidney function impairment (common with tacrolimus), and other drug-specific reactions that can vary from mild to severe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have received a heart transplant.

Select...

I have not undergone desensitization therapy before my transplant.

Select...

My kidney function is within the required range for the study.

Select...

I have received a heart transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have received more than one organ or tissue transplant.

Select...

I have had an organ, tissue, or cell transplant in the past.

Select...

I am not breastfeeding or planning to become pregnant during the study.

Select...

I have had an organ, tissue, or cell transplant in the past.

Select...

I am not breastfeeding or planning to become pregnant during the study.

Select...

I am a candidate for multiple organ or tissue transplants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 18 months post-transplantation, assessed at baseline, month 1, 12 and 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 18 months post-transplantation, assessed at baseline, month 1, 12 and 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 18 months post-transplantation, assessed at baseline, month 1, 12 and 18 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in Chronic Kidney Disease (CKD) stage measured using the mean difference on a continuous measurement scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Belatacept + Tacrolimus withdrawalExperimental Treatment4 Interventions

1. Maintenance Immunosuppression: NULOJIX (belatacept) 2. Maintenance Immunosuppression: CellCept (mycophenolate mofetil- MMF), or Myfortic (mycophenolate sodium) 3. Calcineurin Inhibitors (CNI) Taper: Prograf® (tacrolimus), or tacrolimus generic 4. Corticosteroid: Prednisone (no less than 5mg per day continued throughout the study period)

Group II: Standard-of-CareActive Control3 Interventions

1. Maintenance Immunosuppression: Prograf (tacrolimus), or tacrolimus generic; 2. Maintenance Immunosuppression: CellCept (mycophenolate mofetil- MMF), or Myfortic (mycophenolate sodium); 3. Corticosteroid +/- taper: Prednisone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tacrolimus

2019

Completed Phase 4

~5510

Belatacept

2013

Completed Phase 4

~2210