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AzTrials

Heart TransplantPhase 2NCT03644667

Tocilizumab in Cardiac Transplantation

A Phase 2 study testing tocilizumab in people with Heart Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Transplant
What is being tested?
tocilizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
385 participants
Where
20 sitesUnited States
Study dates
20 Dec 2018to 25 Mar 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be able to understand and provide informed consent;
  • Is a candidate for a primary heart transplant (listed as a heart transplant only);
  • No desensitization therapy prior to transplant;
  • 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 child-bearing potential must consult with their physician and determine the most suitable method(s) from the above referenced list to be used for the duration of the study
  • Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug.
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  • Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted;
  • In the absence of contraindication, vaccinations should be up to date for hepatitis B, influenza, pneumococcal, zoster, and Measles, Mumps, \& Rubella (MMR); and
  • Subjects from areas of endemic coccidioidomycosis are eligible for inclusion but must be treated prophylactically with fluconazole or itraconazole.
  • Recipient of a primary heart transplant;
  • Negative virtual crossmatch (according to local center criteria);
  • No desensitization therapy prior to transplant;
  • Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization; and
  • 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 child-bearing potential must consult with their physician and determine the most suitable method(s) from the above referenced list to be used for the duration of the study
  • Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug.
  • Negative SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test result performed within 48 hours of transplant (SARS-CoV-2 is the virus that causes COVID-19)

Who cannot join

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
  • Candidate for a multiple solid organ or tissue transplants;
  • Prior history of organ or cellular transplantation requiring ongoing systemic immunosuppression;
  • 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 tocilizumab (Actemra®);
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  • Previous treatment with tocilizumab (Actemra®);
  • Human Immunodeficiency Virus (HIV) positive;
  • Hepatitis B surface antigen positive;
  • Hepatitis B core antibody positive;
  • Hepatitis C virus antibody positive (anti-HCV Ab+) who are either untreated or, have failed to demonstrate sustained viral remission for more than 12 months (after anti-viral treatment);
  • Recipient of a Hepatitis C virus nucleic acid test (NAT) positive donor organ;
  • Subjects must be tested for latent TB infection (LTBI) within a year prior to transplant:
  • --Subjects with a positive test for LTBI must complete appropriate therapy for LTBI.
  • ---A Subject is considered eligible only if they have a negative test for LTBI within one year prior to transplant OR
  • ---- if they have completed appropriate LTBI therapy within one year prior to transplant.
  • Subjects with a previous history of active Tuberculosis (TB);
  • Subjects with a history of splenectomy;
  • Known active current viral, fungal, mycobacterial or other infections not including (left ventricular assist device [LVAD]) driveline infections;
  • History of malignancy less than 5 years in remission.
  • --Any history of adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin will be permitted.
  • History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura;
  • History of demyelinating disorders such as:
  • multiple sclerosis,
  • chronic inflammation,
  • demyelinating polyneuropathy.
  • History of gastrointestinal perforations, active inflammatory bowel disease or diverticulitis;
  • Any previous treatment with alkylating agents such as chlorambucil or, total lymphoid irradiation;
  • Radiation therapy within 3 weeks before enrollment.
  • --Enrollment of subjects who require concurrent radiotherapy should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
  • Subjects with a hemoglobin <7.0gm/dL (last measurement within 7 days prior to transplant);
  • Subjects with a platelet count of less than 100,000/mm^3 (last measurement within 7 days prior to transplant);
  • Subjects with an absolute neutrophil count (ANC) of less than 2,000/mm^3 (last measurement within 7 days prior to transplant);
  • Subjects with Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels >3 x Upper Limit of Normal (ULN);
  • Subjects who are administered or intended to be administered cytolytic or anti-cluster of differentiation 25 (CD25) monoclonal antibody agents as induction therapy in the immediate post-transplant period;
  • Intent to give the recipient a live vaccine within 30 days prior to randomization;
  • 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 study,
  • may interfere with the participant's ability to comply with study requirements, or
  • that may impact the quality or interpretation of the data obtained from the study.
  • Recipient of multiple solid organ or tissue transplants;
  • Recipient of ex vivo preserved hearts and hearts donated after cardiac death (DCD);
  • 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 tocilizumab (Actemra®);
  • Previous treatment with tocilizumab (Actemra®);
  • HIV positive;
  • Hepatitis B surface antigen positive;
  • Hepatitis B core antibody positive;
  • Hepatitis B negative transplant recipient that received a transplant from a hepatitis B core antibody positive donor;
  • HCV+ subject(s) who are either untreated or have failed to demonstrate sustained viral remission for more than 12 months after anti-viral treatment;
  • Recipient of a hepatitis C virus nucleic acid test (NAT) positive donor organ;
  • Subject's organ donor tests positive for SARS-CoV-2 by real-time reverse transcription polymerase chain reaction (SARS-CoV-2 is the virus that causes COVID-19).
  • Subjects with a previous history of active (TB);
  • Subjects must be tested for latent TB infection (LTBI) within a year prior to transplant:
  • --Subjects with a positive test for LTBI must complete appropriate therapy for LTBI.
  • ---A Subject is considered eligible only if they have a negative test for LTBI within one year prior to transplant OR
  • ---- if they have completed appropriate LTBI therapy within one year prior to transplant.
  • Subjects with a history of splenectomy;
  • Known active current viral, fungal, mycobacterial or other infections, not including (left ventricular assist device [LVAD]) driveline infections;
  • History of malignancy less than 5 years in remission.
  • --Any history of adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin will be permitted.
  • History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura;
  • History of demyelinating disorders;
  • History of gastrointestinal perforations, active inflammatory bowel disease or diverticulitis;
  • Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation;
  • Radiation therapy within 3 weeks before randomization.
  • --Enrollment of subjects who require concurrent radiotherapy should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
  • Subjects with a hemoglobin <7.0gm/dL within 7 days prior to randomization;
  • Subjects with a platelet count of less than 100,000/mm^3 within 7 days prior to randomization;
  • Subjects with an absolute neutrophil count (ANC) of less than 2,000/mm^3 within 7 days prior to randomization;
  • Subjects with AST or ALT levels >3 x ULN;
  • Subjects who are administered or intended to be administered cytolytic or anti- CD25 monoclonal antibody agents as induction therapy in the immediate post- transplant period;
  • Receipt of a live vaccine within 30 days prior to randomization;
  • Use of 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 study,
  • may interfere with the participant's ability to comply with study requirements, or
  • that may impact the quality or interpretation of the data obtained from the study.
  • Subjects with known donor-specific antibody at the time of evaluation of antibodies for heart transplant surgery (within 6 months).

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Cedars Sinai Medical Center (CACS)

    Beverly Hills, California, 90211

  • Tufts Medical Center (MANM)

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital (MAMG)

    Boston, Massachusetts, 02114

  • Northwestern Memorial Hospital (INLM)

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation (OHCC)

    Cleveland, Ohio, 44195

  • Baylor University Medical Center (TXTX)

    Dallas, Texas, 75246

  • Duke University Medical Center (NCDU)

    Durham, North Carolina, 27710

  • Penn State Health: Milton S. Hershey Medical Center (PAHE)

    Hershey, Pennsylvania, 17033

  • St. Luke's Hospital of Kansas City (MOLH)

    Kansas City, Missouri, 64111

  • University of California, San Diego: Sulpizio Cardiovascular Center (CASD)

    La Jolla, California, 92037

  • Vanderbilt University Medical Center (TNVU)

    Nashville, Tennessee, 37232

  • Mount Sinai Medical Center (NYMS)

    New York, New York, 10029

  • Columbia University Medical Center (NYCP)

    New York, New York, 10032

  • University of Nebraska Medical Center (NEUN)

    Omaha, Nebraska, 68198

  • Hospital of the University of Pennsylvania (PAUP)

    Philadelphia, Pennsylvania, 19104

  • Allegheny General Hospital (PAAG)

    Pittsburgh, Pennsylvania, 15212

  • University of Utah (UTMC)

    Salt Lake City, Utah, 84132

  • Stanford Health Care (CASU)

    Stanford, California, 94305

  • Tampa General Hospital (FLTG)

    Tampa, Florida, 33606

  • Montefiore Medical Center (NYMA)

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Targeting Inflammation and Alloimmunity in Heart Transplant Recipients With Tocilizumab (RTB-004)

The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.

Read the detailed description

This is a prospective, multi-center phase 2 clinical trial in which 200 primary heart transplant recipients will be randomized (1:1) to receive either tocilizumab (Actemra®) or placebo (normal saline) plus standard triple maintenance immunosuppression. Investigators will recruit primary heart transplant recipients from 14 participating centers. Subjects will be screened, consented, and enrolled while on the United Network for Organ Sharing (UNOS) wait list. When the recipient has received the transplant and is deemed hemodynamically stable, randomization will occur.

Study duration: The study duration will be approximately 4 years. There will be a 36-month accrual period, and participants will be followed for a minimum 12-month, and a maximum 24 months after heart transplantation.

  • IMPORTANT NOTICE: * The National Institute of Allergy and Infectious Diseases does not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.
Being tested
tocilizumab, Placebo, Standard of Care Triple IS
Keywords
heart transplant recipients, alloimmunity, anti-inflammatory, tocilizumab, efficacy clinical trial, immunosuppression (IS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tocilizumabBiological

    Also called Actemra®

    6 doses: 8mg/kg (maximum of 800 mg) given once every four weeks by intravenous infusion over a 20-week period, with a minimum of 21 days between each infusion.

  • PlaceboBiological

    Also called Placebo for tocilizumab, Placebo for Actemra®

    The placebo is 0.9% sterile normal saline. 6 doses: 8mg/kg (maximum of 800 mg) given once every four weeks by intravenous infusion over a 20-week period, with a minimum of 21 days between each infusion.

  • Standard of Care Triple ISDrug

    Also called calcineurin inhibitor: (tacrolimus (Prograf ®)), anti-proliferative treatment: (mycophenolate mofetil ),, MMF, CellCept®, Myfortic®, enteric-coated mycophenolate sodium

    Standard of care triple maintenance IS includes:

    1. A calcineurin inhibitor-tacrolimus (Prograf ®) per site standards by sublingual, oral or intravenous route to attain target trough levels. Exception: Should a participant be unable to tolerate tacrolimus, the site physician investigator may choose cyclosporine treatment.
    2. An anti-proliferative treatment-mycophenolate mofetil or Myfortic® (enteric-coated mycophenolate sodium) will be administered, per protocol. Exception: Should a participant be unable to tolerate mycophenolate mofetil, the site physician investigator may choose an alternative treatment.
    3. Steroids-methylprednisolone/prednisone dosing will be given according to the local center standard of practice early post transplantation. After 6 months, prednisone may be withdrawn at the discretion of the site physician investigator, per protocol.
Study groups in NCT03644667
Study groupRoleWhat they receive
Tocilizumab + Standard of Care Triple ISExperimentalTocilizumab plus standard of care triple immunosuppression (IS). Heart transplant recipients will receive tocilizumab (Actemra®) plus standard triple maintenance immunosuppression. Standard of care triple maintenance immunosuppression includes: * a calcineurin inhibitor (tacrolimus), * an anti-proliferative treatment (mycophenolate mofetil) or Myfortic® (enteric-coated mycophenolate sodium), and * steroids (methylprednisolone/prednisone) as prescribed by site physician investigator. Participants enrolled in the study will be followed for 24 months after their transplant surgery. Randomization will occur once a participant has weaned from cardiopulmonary bypass and has achieved hemodynamic stability without significant ongoing bleeding within the first 72 hours after transplant.
Receives: Biological: tocilizumab; Drug: Standard of Care Triple IS
Placebo + Standard of Care Triple ISPlacebo comparatorPlacebo plus standard of care triple maintenance immunosuppression (IS). Heart transplant recipients will receive placebo plus standard triple maintenance immunosuppression. Standard of care triple maintenance immunosuppression includes: * a calcineurin inhibitor (tacrolimus), * an anti-proliferative treatment (mycophenolate mofetil) or Myfortic® (enteric-coated mycophenolate sodium), and * steroids (methylprednisolone/prednisone) as prescribed by site physician investigator. Participants enrolled in the study will be followed for 24 months after their transplant surgery. Randomization will occur once a participant has weaned from cardiopulmonary bypass and has achieved hemodynamic stability without significant ongoing bleeding within the first 72 hours after transplant.
Receives: Biological: Placebo; Drug: Standard of Care Triple IS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Positive for Event of dnDSA, ACR, AMR, Hemodynamic Compromise, Death or Re-Transplantation

    The primary endpoint is defined by a composite 1 year post-transplant endpoint of:

    1. Any detection of de novo donor-specific antibodies (dnDSA) (as assessed by the Core Laboratory),
    2. Acute cellular rejection (ACR) ≥ ISHLT 2R rejection (as assessed by the Core Laboratory),
    3. Antibody mediated rejection (AMR) ≥ ISHLT AMR 1 (as assessed by the Core Laboratory),
    4. Hemodynamic compromise rejection whether or not a biopsy is performed and whether or not there is biopsy-proven rejection (as assessed by the Core Laboratory). The following criteria are required for hemodynamic compromise:
    • The need for inotropic agents due to either cardiac index <2.0 L/min/m2 or clinical evidence of acute decompensated heart failure
    • Ejection fraction of ≤40%
    1. Death,
    2. Re-transplantation.

    Measured: From transplant through 12 months post transplant surgery (12 months)

Secondary outcomes (20)

  1. Freedom of Detection of de Novo Donor-Specific Antibodies (dnDSA)

    A comparison by treatment group of the cumulative incidence of freedom from development of de novo donor-specific antibodies (dnDSA). dnDSA is a newly developed alloantibody that is against the donor organ. The numbers presented in the "Measured Values" table represent the cumulative incidence (accounting for the competing risk of death) of the event in each group.

    Measured: From transplant through 12 months post transplant surgery (12 months)

  2. Freedom From Acute Cellular Rejection (ACR) ≥ International Society of Heart and Lung Transplantation (ISHLT) 2R Rejection

    A comparison by treatment group of the cumulative incidence of freedom from development of acute cellular rejection ≥2R (Reference: International Society of Heart and Lung Transplantation [ISHLT] acute cellular rejection-grade 2R or greater severity). The numbers presented in the "Measured Values" table represent the cumulative incidence (accounting for the competing risk of death) of the event in each group.

    Measured: From transplant through 12 months post transplant surgery (12 months)

  3. Freedom From Antibody Mediated Rejection (AMR) ≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1 - by Treatment Group

    A comparison by treatment group of the cumulative incidence of freedom from development of antibody-mediated rejection defined as ISHLT grade AMR 1 or greater severity. The numbers presented in the "Measured Values" table represent the cumulative incidence (accounting for the competing risk of death) of the event in each group.

    Measured: From transplant through 12 months post transplant surgery (12 months)

  4. Freedom From Hemodynamic Compromise Rejection Whether or Not a Biopsy is Performed and Whether or Not There is Biopsy-proven Rejection

    A comparison by treatment group of the cumulative incidence of freedom from development of hemodynamic compromise (HDC).

    The following criteria are required for hemodynamic compromise:

    • The need for inotropic agents due to either cardiac index <2.0 L/min/m2 or clinical evidence of acute decompensated heart failure
    • Ejection fraction of ≤40% The numbers presented in the "Measured Values" table represent the cumulative incidence (accounting for the competing risk of death) of the event in each group.

    Measured: From transplant through 12 months post transplant surgery (12 months)

  5. Freedom From Any-Treated Rejection

    A comparison by treatment group of the cumulative incidence of freedom from development of episode of rejection requiring treatment. Reference: Acute cellular rejection as defined by the 2004 International Society of Heart and Lung Transplantation (ISHLT) grading scale. The numbers presented in the "Measured Values" table represent the cumulative incidence (accounting for the competing risk of death) of the event in each group.

    Measured: From transplant through 12 months post transplant surgery (12 months)

  6. Occurrence of Death

    Incidence of all-cause mortality will be compared between the treatment groups.

    Measured: From transplant through 12 months post transplant surgery (12 months)

  7. Occurrence of Re-Listed for Transplantation

    Incidence of participant(s) being re-listed for transplant will be compared between the treatment groups.

    Measured: From transplant through 12 months post transplant surgery (12 months)]

  8. Occurrence of Re-Transplantation

    Incidence of participant(s) re-transplantation will be compared between the treatment groups.

    Measured: From transplant through 12 months post transplant surgery (12 months)

  9. Number of Acute Cellular Rejection (≥ International Society of Heart and Lung Transplantation (ISHLT) 2R) Per Patient

    The frequency of events will be compared between the treatment groups. The numbers presented in the "Measured Values" table represent the event rate per patient-year in each group.

    Measured: From transplant through 12 months post transplant surgery (12 months)

  10. Number of Antibody Mediated Rejection (AMR) (≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1) Per Participant

    The frequency of events will be compared between the treatment groups. The numbers presented in the "Measured Values" table represent the event rate per patient-year in each group.

    Measured: From transplant through 12 months post transplant surgery (12 months)

  11. Number of Rejection Episodes Associated With Hemodynamic Compromise (HDC)

    The frequency of events will be compared between the treatment groups.

    Measured: From transplant through 12 months post transplant surgery (12 months)]

  12. Change in Intravascular Ultrasound (IVUS) Measurements From Baseline to 1 Year Post-Transplant

    Percent atheroma volume (PAV) Per protocol, per clinical research site standard of care.

    Measured: Baseline (4 to 8 weeks post-transplant), 1 year post-transplant

  13. Change in Intravascular Ultrasound (IVUS) Measurements From Baseline to 1 Year Post-Transplant

    Maximal intimal thickness (MIT) Per protocol, per clinical research site standard of care.

    Measured: Baseline (4 to 8 weeks post-transplant), 1 year post-transplant

  14. Angiographic Evidence of Cardiac Allograft Vasculopathy (CAV)

    In accordance with the International Society of Heart and Lung Transplantation (ISHLT) Cardiac Allograft Vasculopathy (CAV) angiographic grading scale ranging from 0 (no disease) to 3 (severe disease)

    Measured: 12 months post transplantation

  15. Participant Loss to Follow up

    Incidence of participant loss to follow up (including withdrawal of consent) will be compared between the treatment groups.

    Measured: 12 months post-transplantation

  16. Occurrence of Serious Infections Requiring Intravenous Antimicrobial Therapy and Need for Hospitalization

    The frequency of serious infections requiring intravenous antimicrobial therapy and need for hospitalization will be compared between treatment groups.

    Measured: Through 24 months post transplant surgery

  17. Incidence of Tuberculosis

    The incidence of tuberculosis will be compared between treatment groups.

    Measured: Through 24 months post transplant surgery

  18. Incidence of Cytomegalovirus (CMV) Infection

    The incidence of CMV infection will be compared between treatment groups.

    Measured: Through 24 months post transplant surgery

  19. Incidence of Post-Transplant Lymphoproliferative Disease (PTLD)

    The incidence of PTLD will be compared between treatment groups.

    Measured: Through 24 months post transplant surgery

  20. Tolerability (Discontinuation of Study Drug) of Tocilizumab (TCZ)

    The number of participants who discontinue study drug, per protocol, will be compared between treatment groups. The count includes patients who withdrew consent and losses to follow-up.

    Measured: Through 24 months post transplant surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2018
  2. Study start20 Dec 2018
  3. Primary completion25 Mar 2025
  4. Study completion25 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03644667
Sponsor's protocol ID
DAIT RTB-004
Other IDs
ALL IN, U01AI136816
Status last verified
Sep 2026
First submitted
21 Aug 2018
Last updated
29 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tocilizumab in people with Heart Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 80 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Positive for Event of dnDSA, ACR, AMR, Hemodynamic Compromise, Death or Re-Transplantation (time frame: From transplant through 12 months post transplant surgery (12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03644667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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