New drug combo aims to protect transplanted hearts
NCT ID NCT03292861
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding Thymoglobulin to standard anti-rejection drugs helps prevent complications after a first heart transplant. About 60 adults will receive either standard therapy alone or standard therapy plus five days of Thymoglobulin. Researchers will check for signs of rejection and artery disease over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Thymoglobulin (an anti-rejection drug given intravenously)
- What this could lead to
- If it works, this could reduce the risk of heart transplant rejection and artery damage, helping transplanted hearts last longer.
- What could go wrong
- This is a small, early-phase study at one center, so results may not apply widely. Thymoglobulin can cause serious side effects like infections or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2018
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Study Entry: 1. Subjects must be undergoing their first allograft transplant 2. Men and non-pregnant women must be 18 to 70 years old 3. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to transplantation. The sensitivity must be equal to at least 50 mIU/mL. (Urine test is allowed in addition to serum test in patients where serum results are delayed) 4. Men with a female partner of child bearing age and women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy. 5. Subjects must be willing and capable of understanding the purpose and risks of the study, and must sign a statement of informed consent 6. Subjects with a Creatinine \< 2.0 mg/dl at time of transplant Exclusion Criteria for Study Entry: 1. Allergy to Thymoglobulin-Thymoglobulin is contraindicated in patients with history of allergy or anaphylaxis to rabbit proteins or to any product excipients, or who have active acute or chronic infections which contraindicate any additional immunosuppression 2. Previous organ transplants 3. Patients receiving multiple organs 4. Patients with a BMI higher than 35 5. Patients with PRA ≥ 25% 6. Patients requiring VAD upon completion of transplantation surgery. 7. HIV-1, HTLV-1, chronic Hepatitis B, or chronic Hepatitis C infection 8. Documented or strong suspicion for pre-operative active infection that has not yet been adequately treated with the recommended course of antimicrobial therapy 9. Presence of any chronic myelosuppressive disease or agent that has resulted in either chronic leucopenia or chronic thrombocytopenia 10. Active peptic ulcer disease and active GI bleeding 11. Patients who have received within the past 30 days or require concomitant treatment with other investigational drugs (except for those listed in section 8.6 "Concomitant treatment") 12. Patients with a history of AL amyloidosis (TTR amyloids) are permitted
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
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