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Immunosuppressant

Thymoglobulin Induction Therapy for Heart Transplant Recipients

Phase 2
Waitlist Available
Led By Jon Kobashigawa, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with a Creatinine < 2.0 mg/dl at time of transplant
Men and non-pregnant women must be 18 to 70 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months, 12 months
Awards & highlights

Study Summary

This trial will evaluate whether Thymoglobulin induction therapy can help prevent CAV. Patients will be given Thymoglobulin via IV infusion on 5 different days immediately post-operation. Assays will be performed to measure the efficacy of the therapy.

Who is the study for?
This trial is for first-time heart transplant recipients aged 18-70 with functioning kidneys (Creatinine < 2.0 mg/dl). Women must test negative for pregnancy and use two forms of contraception, as should men with childbearing partners. Exclusions include allergies to Thymoglobulin or rabbit proteins, active infections, peptic ulcers, previous transplants, BMI over 35, certain viral infections like HIV or Hepatitis B/C, blood disorders, recent investigational drugs usage except those listed in the study details.Check my eligibility
What is being tested?
The trial tests if Thymoglobulin induction therapy combined with Mycophenolate Mofetil, tacrolimus and steroids can prevent chronic allograft vasculopathy (CAV) post-heart transplant. Participants are randomly assigned to receive either Thymoglobulin or not alongside standard care; their immune cell levels and cytokines will be monitored at intervals.See study design
What are the potential side effects?
Thymoglobulin may cause side effects such as allergic reactions to rabbit proteins present in it. Other potential risks include increased susceptibility to infection due to additional immunosuppression from the treatment regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My creatinine level is below 2.0 mg/dl before a transplant.
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I am between 18 and 70 years old and not pregnant.
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I am using two reliable birth control methods during and 4 months after the study.
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I am getting my first transplant from a donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Composite Efficacy Failure at 12 Months
Secondary outcome measures
Antibody mediated rejected
Any treated rejection
Cardiac Allograft Vasculopathy (CAV)
+26 more

Trial Design

2Treatment groups
Active Control
Group I: Thymoglobulin®Active Control5 Interventions
Thymoglobulin® (Genzyme) [rabbit anti-thymocyte globulin (ATG)] is a purified pasteurized, gamma immune globulin, obtained by immunization of rabbits with human thymocytes. This immunosuppressive product contains polyclonal cytotoxic antibodies directed against antigens expressed on human T-lymphocytes. Approximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 6 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4 hours. In addition, there will be maintenance doses of mycophenolate mofetil, tacrolimus, sirolimus, and cumulative dose of corticosteroids at 12 months post-transplantation
Group II: No induction therapyActive Control1 Intervention
Patients qualifying for the study will be randomized before the transplantation surgery in a 1:1 ratio to either Thymoglobulin® or no treatment.

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,570 Total Patients Enrolled
Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,797 Total Patients Enrolled
Jon Kobashigawa, MDPrincipal InvestigatorDirector

Media Library

Thymoglobulin (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT03292861 — Phase 2
Heart Transplant Research Study Groups: Thymoglobulin®, No induction therapy
Heart Transplant Clinical Trial 2023: Thymoglobulin Highlights & Side Effects. Trial Name: NCT03292861 — Phase 2
Thymoglobulin (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03292861 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what conditions does Thymoglobulin® typically provide relief?

"Thymoglobulin® may be utilized to effectively manage a variety of conditions, such as immunosuppressive treatment, dermatitis atopicum and organ rejection; primarily in cases where kidney transplantation is necessary."

Answered by AI

Has Thymoglobulin® been used in prior clinical research studies?

"At present, 320 separate clinical trials are analyzing the efficacy of Thymoglobulin®, with 42 studies in Phase 3. Philadelphia is hosting a handful of these investigations; however, there are 2429 other sites running trails for this medication."

Answered by AI

Who qualifies for participation in this research endeavor?

"This clinical trial seeks 60 individuals, 18 to 70 years of age, who have recently received a heart transplant. Additionally, these participants must satisfy the following conditions: be undergoing their first allograft; demonstrate negative pregnancy test results with a sensitivity level equivalent to at least 50 mIU/mL (urine tests are accepted when serum results cannot be obtained); men and women of reproductive potential should use two forms of contraception for four months after discontinuing study drug therapy; display willingness and capability in understanding the purpose and risks associated with the trial evidenced via statement of informed consent; present creatinine levels lower than 2 mg/dL upon receiving organ"

Answered by AI

Are further participants required for this trial?

"According to the information present on clinicaltrials.gov, this medical trial is no longer recruiting patients. Initially listed in September of 2018 and last amended by November 2022, this study has concluded enrollment; however there are still 329 ongoing trials searching for participants."

Answered by AI

How many participants are engaged in this clinical trial?

"This clinical trial has ceased recruiting participants, with the last update being November 11th 2022. For other studies, 9 trials related to heart transplants are actively enrolling and 320 Thymoglobulin® trails require patients."

Answered by AI

Has the FDA approved Thymoglobulin® for public use?

"Our team at Power assigned Thymoglobulin® a safety rating of two due to the data collected during Phase 2 trials, which suggests some level of efficacy but no evidence confirming its effectiveness."

Answered by AI

Do elderly participants aged 80 and older qualify for the experiment?

"As per the eligibility criteria of this study, individuals between 18 and 70 years old are suitable participants. Separately, there exist 133 trials for minors and 248 studies open to seniors."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
Jon Kobashigawa 2018. "The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03292861.
~5 spots leftby Oct 2024
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