BridgeMD
New treatment option for Heart Transplant
Official title Belatacept in Heart Transplantation
ClinicalTrials.gov ID: NCT06478017
What this study is testing
What is Belatacept?
Belatacept is an investigational medicine, being studied as a potential treatment for heart transplant.
Also referred to as NULOJIX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 2, prospective, multi-center, open-label clinical trial. Sixty-six (66) primary heart transplant recipients will be randomized (1:2) to receive either standard-of-care, tacrolimus-based immunosuppression, or a belatacept-based regimen with gradual tacrolimus withdrawal over 9-months post-transplant.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 9 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 71
You may be able to join if
- Study entry
- Subject must be able to understand the purpose of the study and be willing to participate and provide written consent
- Recipient of a primary heart transplant (heart transplant only)
- Epstein-Barr Virus (EBV) seropositive (VCA IgG, EBNA IgG). If EBNA is not available, enrollment may proceed but the result must be available prior to...
- Agreement to use contraception; according to the Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol), there...
You likely can't join if
- Study entry
- Candidate for multiple solid organ or tissue transplants
- Prior history of any organ, tissue, or cellular transplant
- Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period
- History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies
- Known hypersensitivity to NULOIX (belatacept) or ORENCIA (Abatacept)
See the full eligibility criteria
Who can join
- Study entry
- Subject must be able to understand the purpose of the study and be willing to participate and provide written consent
- Recipient of a primary heart transplant (heart transplant only)
- Epstein-Barr Virus (EBV) seropositive (VCA IgG, EBNA IgG). If EBNA is not available, enrollment may proceed but the result must be available prior to randomization.
- Agreement to use contraception; according to the Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80%...
- In the absence of a contraindication, vaccinations must be up to date per the Division of Allergy, Immunology, and Transplantation (DAIT) Vaccination Guidance for Patients in Transplant Trials...
- Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted. Randomization
- Recipient of a primary heart transplant
- No desensitization therapy prior to transplant
- Negative crossmatch actual or virtual, on the most recent sera as determined by the participating study center
- Female people of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization
- Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of...
- Pre-transplant eGFR (CKD-epi) \>30ml/min/1.73m\^2. If eGFR \<30ml/min/1.73m\^2 at the time of randomization, participation is permitted if the study physician determines that renal recovery is expected. Participants who...
What rules you out
- Study entry
- Candidate for multiple solid organ or tissue transplants
- Prior history of any organ, tissue, or cellular transplant
- Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period
- History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies
- Known hypersensitivity to NULOIX (belatacept) or ORENCIA (Abatacept)
- Previous treatment with NULOIX (belatacept) or ORENCIA (Abatacept)
- Epstein Barr Virus (EBV) seronegative or indeterminant
- Human Immunodeficiency Virus (HIV) positive
- Hepatitis B surface antigen positive
- Hepatitis B core antibody positive
- Hepatitis C virus antibody (HCV Ab+) and hepatitis C virus (HCV) Polymerase Chain Reaction (PCR) positive patients
- Patients with active Tuberculosis (TB) in the past 2 years, whether or not it was adequately treated; patients with documented treatment of active TB greater than 2 years ago will be allowed to participate if there is...
- people must be tested for latent TB infection (LTBI) within a year prior to transplant. Testing should be conducted using either a PPD or Interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB). Patients with a...
- Positive serology for T. cruzi or known/suspected history of Chagas disease
- Participants currently or formerly residing in regions of the US that are highly endemic for coccidiomycosis will undergo serological testing, as per the site's standard of care. Participants with positive serology who...
- Findings on pre-transplant or pre-randomization chest x-ray or CT scan suggestive of fungal infection where an alternative etiology is not identified. Participants with a history of positive serologies for...
- Known active current viral, fungal, mycobacterial or other infections (including, but not limited to atypical mycobacterial disease and herpes zoster), not including drive line infections
- Current white blood cell (WBC) count \<3.0 or an absolute neutrophil count (ANC) of less than 1500 cells/mm\^3 or recurrent leukopenia that is likely to necessitate immunosuppression reduction after transplant, as...
- History of active inflammatory bowel disease, chronic diarrhea, or malabsorption
- History of malignancy, per discretion of oncology consult and study oversight team, will be permitted to participate
- History of AL amyloidosis
- Patients who are administered or intended to be administered induction therapy (cytolytic agents such as anti-thymocyte globulin or anti-IL2R therapies such as basiliximab) in the immediate peri-transplant period
- Patients who i) have undergone desensitization, ii) are undergoing or are planned to undergo desensitization, or iii) are intended to receive therapeutic interventions that are used for the purpose of desensitization...
- Pretransplant Calculated Panel Reactive Antibody (cPRA) \> 50% as defined by local site practices
- The use of immunosuppressive biologics within 1 month prior to transplant is not permitted. Non-immunosuppressive biologics such as proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors must be stopped at the...
- Patients for whom there is an intent to administer biologics other than those indicated by protocol during the study period
- The intended use of high dose (\>= 2g/kg) intravenous immunoglobulin before or at the time of transplant or before study drug administration
- A personal history of severe hypogammaglobulinemia (\<300mg/dL)
- Intent to give the patient a live vaccine within 30 days prior to randomization
- Use or intended use of other investigational drugs after transplant
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
- Recipient of multiple solid organ or tissue transplants
- Prior history of any organ, tissue, or cellular transplant
- Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period
- History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies
- Known hypersensitivity to Belatacept (NULOJIX) or Abatacept (ORENCIA)
- Previous treatment with Belatacept (NULOJIX) or Abatacept (ORENCIA)
- Epstein Barr Virus (EBV) seronegative or indeterminant (recipient must be seropositive for VCA IgG and EBNA IgG)
- HIV positive patient
- Hepatitis B surface antigen positive patient
- Hepatitis B core antibody positive patient
- Hepatitis B negative transplant recipient that received a transplant from a Hepatitis B core antibody positive donor
- Hepatitis C virus antibody (HCV Ab+) and HCV PCR positive patients
- Recipient of allograft from a hepatitis C virus nucleic acid test (NAT) positive donor
- Patients with a previous history of active Tuberculosis (TB) in the past 2 years, whether or not it was adequately treated; patients with documented treatment of active TB greater than 2 years ago will be allowed to...
- people must be tested for latent TB infection (LTBI) within a year prior to transplant. Testing should be conducted using either a PPD or Interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB). Patients with a...
- Positive serology for T. cruzi or known/suspected history of Chagas disease
- Participants currently or formerly residing in regions of the US that are highly endemic for coccidiomycosis will undergo serological testing, as per the site's standard of care. Participants with positive serology who...
- Findings on pre-transplant or pre-randomization chest x-ray or CT scan suggestive of fungal infection where an alternative etiology is not identified. Participants with a history of positive serologies for...
- Known active current viral, fungal, mycobacterial or other infections (including, but not limited to atypical mycobacterial disease and herpes zoster), not including drive line infections
- Current white blood cell (WBC) count \<3.0 or an absolute neutrophil count (ANC) of less than 1500 cells/mm\^3 or recurrent leukopenia that is likely to necessitate immunosuppression reduction after transplant, as...
- CMV high risk mismatch (D+/R-)
- History of active inflammatory bowel disease, chronic diarrhea, or malabsorption
- History of malignancy, per discretion of oncology consult and study oversight team, will be permitted to participate
- History of AL amyloidosis
- Patients who are administered or intended to be administered induction therapy (cytolytic agents such as anti-thymocyte globulin or anti-IL2R therapies such as basiliximab) in the immediate peri-transplant period
- Patients who have undergone desensitization or received therapeutic interventions that are used for the purpose of desensitization prior to transplant
- cPRA \> 50% at the time of transplant or any donor specific antibodies before or at the time of transplant as determined by local site practices
- Patients who have been treated with immunosuppressive biologics within 1 month prior to transplant (non-immunosuppressive biologics must have been stopped at the time of transplant)
- Patients for whom there is an intent to administer biologics other than those indicated by protocol during the study period
- Patients who are administered or intended to be administered high dose (\>=2g/kg) intravenous immunoglobulin in the immediate post-transplant period
- A personal history of severe hypogammaglobulinemia (\<300mg/dL)
- Receipt of a live vaccine within 30 days prior to randomization
- Intent to use any other investigational drugs after transplantation
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 9 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 71 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Kansas City, Missouri, United States; New York, New York, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.