What side effects are associated with this type of intervention?

Common treatments for heart transplant to prevent organ rejection include calcineurin inhibitors (e.g., tacrolimus, cyclosporine), mTOR inhibitors (e.g., sirolimus, everolimus), mycophenolate mofetil, and corticosteroids. These treatments can cause side effects such as nephrotoxicity, hypertension, hyperlipidemia, diabetes, and increased risk of infections and malignancies. Belatacept, which inhibits T-cell activation, is being studied for its safety in heart transplant recipients. Known side effects of Belatacept include increased risk of infections, post-transplant lymphoproliferative disorder (PTLD), and infusion-related reactions. Overall, while Belatacept may offer a different side effect profile, it shares common risks associated with immunosuppressive therapies.

What prior FDA approvals exist?

FDA-approved treatments for heart transplant patients that prevent organ rejection by inhibiting T-cell activation include drugs like tacrolimus and cyclosporine. Tacrolimus, available in both immediate-release (Prograf) and extended-release (Advagraf) formulations, is a calcineurin inhibitor that suppresses the immune system by inhibiting T-cell activation. Cyclosporine, another calcineurin inhibitor, also works by preventing T-cell activation and is available in microemulsion formulations to improve pharmacokinetics and tolerability. These drugs are commonly used in combination with other immunosuppressive agents to enhance efficacy and reduce the risk of rejection.

What other types of research exist?

Promising novel alternatives to Belatacept for heart transplant patients include: 1) Basiliximab, an IL-2 receptor antagonist used for induction therapy, which has shown efficacy in kidney transplantation. 2) Rabbit antithymocyte globulin (rATG), which is used for induction and has been associated with lower incidence of donor-specific antibodies. 3) Alemtuzumab, a monoclonal antibody targeting CD52, used in induction therapy and showing promise in reducing rejection rates. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Immunosuppressant

Belatacept for Heart Transplant

Phase 2

Recruiting

Led By Marlena V. Habal, MD

Research Sponsored by Marlena V. Habal

Eligibility Criteria Checklist

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

Must have

No desensitization therapy prior to transplant

Male or non-pregnant female, age ≥18 to ≤75 years

Must not have

The need or anticipated need for post-transplant dialysis

Prior treatment with belatacept or abatacept

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months after transplantation

Awards & highlights

Approved for 5 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing if Belatacept is safe for adult heart transplant patients. The medication helps prevent organ rejection by calming the immune system. It aims to improve long-term outcomes for these patients. Belatacept has shown promise in preserving kidney function in previous studies.

Who is the study for?

Adults aged 18-75 awaiting a primary heart transplant, who are EBV seropositive and can take oral meds. They must adhere to belatacept infusion schedule, have up-to-date vaccinations, and females of childbearing age need a negative pregnancy test. Excludes those with prior transplants, certain infections like HIV/HBV/HCV/TB, recent live vaccines, cancer in the last 5 years, high PRA levels or severe allergies to monoclonal antibodies.

What is being tested?

The trial is testing if Belatacept is safe for adult heart transplant recipients as an anti-rejection medication. It's being used investigatively alongside standard post-transplant drugs such as corticosteroids, tacrolimus and mycophenolate mofetil.

What are the potential side effects?

Belatacept may cause side effects including risk of infection due to immune suppression, possible allergic reactions related to infusions and interactions with other medications typically used after transplantation.

Eligibility Criteria

Inclusion Criteria

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

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I have not undergone desensitization therapy before a transplant.

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I am between 18 and 75 years old and not pregnant.

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I can take pills and follow a schedule for receiving belatacept infusions.

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I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

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

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I might need dialysis after a transplant.

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I have been treated with belatacept or abatacept before.

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I have had active tuberculosis in the past.

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I have been treated with cytolytic therapy before.

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I am planned to receive cell-killing therapy after a transplant.

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I have or had HIV, Hepatitis B, or Hepatitis C.

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I have untreated latent TB.

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I was diagnosed with cancer within the last 5 years.

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I have been treated with alkylating agents or had total lymphoid irradiation.

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I am a heart transplant candidate with high immune response or undergoing desensitization treatment.

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I have taken medication for rheumatic disease in the last year.

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I was not on a heart-lung machine for more than 72 hours after my transplant.

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I require strong medication to maintain my blood pressure more than 3 days after a transplant.

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I have had a brain or spinal cord infection before.

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I am currently on medication to suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months after transplantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months after transplantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months after transplantation 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 Major Graft-Related Adverse Events

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BelataceptExperimental Treatment4 Interventions

Participants will receive Belatacept along with an upfront tacrolimus taper Participants will also receive mycophenolate mofetil and corticosteroids are part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belatacept

FDA approved

Corticosteroid

2005

Completed Phase 4

~2210

Tacrolimus

FDA approved

Mycophenolate mofetil

FDA approved

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart transplant patients, such as Belatacept, work by inhibiting T-cell activation, which is essential for preventing organ rejection. Belatacept specifically blocks the costimulatory signals required for T-cell activation, thereby reducing the immune system's ability to attack the transplanted heart. This mechanism is vital for heart transplant patients as it helps maintain the viability of the transplanted organ, reduces the risk of rejection, and improves long-term outcomes. Other immunosuppressive agents, like calcineurin inhibitors (e.g., tacrolimus) and antimetabolites (e.g., mycophenolate), also play a role by targeting different pathways in the immune response, ensuring comprehensive suppression of potential rejection mechanisms.

Belatacept in renal transplant recipient with mild immunologic risk factor: A pilot prospective study (BELACOR).