Published Studies Related to Thymoglobulin (Anti-Thymocyte Globulin)
Randomized trial of thymoglobulin versus alemtuzumab (with lower dose maintenance immunosuppression) versus daclizumab in living donor renal transplantation. [2010.11]
BACKGROUND: We performed a randomized trial evaluating alemtuzumab, a humanized anti-CD52 monoclonal antibody, in living donor (LD) kidney transplantation. METHODS: Thirty-eight LD first renal transplant recipients were randomized into three single-agent antibody induction groups: thymoglobulin (group A); alemtuzumab (group B); and daclizumab (group C)...
Thymoglobulin induction and sirolimus versus tacrolimus in kidney transplant recipients receiving mycophenolate mofetil and steroids. [2010.06.27]
BACKGROUND: To define the role of mammalian target of rapamycin inhibitors in kidney transplantation, we compared efficacy and safety of two immunosuppressive regimens-a calcineurin inhibitor-free regimen with depletive induction versus a calcineurin inhibitor-based regimen... CONCLUSION: Patients treated with induction plus SRL, mycophenolate mofetil, and corticosteroids may obtain good renal function but have a higher risk of adverse events, drug withdrawal, and graft loss.
A prospective, randomized, multicenter study evaluating early corticosteroid withdrawal with Thymoglobulin in living-donor kidney transplantation. [2010.01]
BACKGROUND: This study compared the safety and efficacy of early corticosteroid withdrawal (ECSWD) with rabbit anti-thymocyte globulin (rATG) induction to chronic corticosteroid therapy (CCST) without antibody induction in primary, living-donor renal transplant recipients... CONCLUSIONS: rATG with tacrolimus and MMF therapy may allow early elimination of corticosteroids, is associated with trends toward lower lipid levels, less weight gain, and a safety profile comparable to CCST therapy.
Thymoglobulin induction in liver transplant recipients with a tacrolimus, mycophenolate mofetil, and steroid immunosuppressive regimen: a five-year randomized prospective study. [2009.11]
This randomized, comparative study assessed the long-term efficacy and tolerability of thymoglobulin (TMG) induction in 93 liver transplant patients with an initial regimen of tacrolimus (Tac), mycophenolate mofetil (MMF), and steroids. Forty-four patients were randomly allocated to the TMG+ group, and 49 patients were randomly allocated to the TMG- group...
A prospective, randomized, double-blinded comparison of thymoglobulin versus Atgam for induction immunosuppressive therapy: 10-year results. [2008.10.15]
BACKGROUND: Use of induction for renal transplantation is controversial because of the concerns about long-term safety and efficacy... CONCLUSIONS: This long-term follow-up showed that thymoglobulin was associated with higher event-free survival and improved QALYs, without increased posttransplant lymphoproliferative disorder or cytomegalovirus disease, compared with Atgam at 10 years.
Clinical Trials Related to Thymoglobulin (Anti-Thymocyte Globulin)
A Phase I Study Of Thymoglobulin In Patients With Relapsed Or Refractory Multiple Myeloma [Completed]
To determine the maximum tolerated dose and dose limiting toxicity of thymoglobulin in
multiple myeloma patients.
To determine the overall response rate (CR+PR) of patients with relapsed or refractory
multiple myeloma treated with Thymoglobulin.
To determine the time to response, duration of response, and time to progression and overall
survival of patients treated with Thymoglobulin.
To determine the safety and tolerability of Thymoglobulin in these patients.
To assess the changes in lymphocyte apoptosis and apoptotic signaling in treated patients.
Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation [Recruiting]
This is a randomized trial for patients undergoing hematopoietic progenitor cell
transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled
will receive Thymoglobulin« as part of the preparative regimen prior to HPCT. The other 50%
of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is
known to suppress the types of cells that can cause a transplant complication known as
"chronic graft versus host disease (cGVHD)". The goal of this trial is to find out if
adding Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.
Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation [Recruiting]
In a non-blinded pilot study conducted at the University of Nebraska Medical Center,
evidence was found that a single large dose of Thymoglobulin on the day of kidney
transplantation produced better kidney function than the standard dosing plan, when the same
amount is divided into smaller doses on 4 days. This new study repeats that dose
comparison, but with double-blinding and at multiple transplantation centers.
Thymoglobulin (ATG) Dose Finding Study [Terminated]
- To determine the response and toxicity rate at day 56 of two different dose levels of
thymoglobulin (ATG) [anti-thymocyte globulin (rabbit)] as a treatment of
steroid-refractory acute graft versus host disease (aGVHD).
- To evaluate the response rate at day 28.
- To evaluate the overall survival and non-relapse mortality at 6 months.
- To determine the toxicity profile of thymoglobulin when used for the treatment of
steroid-refractory aGVHD in each of two dose schedules.
- To characterize the pharmacokinetic profile of thymoglobulin in each of two dose
- To analyze biomarkers of cellular drug effect by quantifying T-cell apoptosis in aims
of finding the minimal effective dose.
- To determine immune-reconstitution after administration of thymoglobulin to patients
with steroid-refractory aGVHD for each dose schedule.
Low Dose Thymoglobin in Renal Transplant Patients [Completed]
This is a planned single center prospective randomized study evaluating the safety and
efficacy of low dose thymoglobulin as induction agent in renal transplant recipients.
Inclusion criteria will be adult renal transplant recipients who are not sensitized against
their potential donors. The patients who agree to participate in the study will be randomly
assigned to either thymoglobulin at 1. 25mg/kg x 3 doses or 0. 75mg/kg x 3 doses. There will
be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1. 25mg/kg
dosing and the other 43 envelopes with 0. 75mg/kg dosing. The investigators will sequentially
choose the sealed envelopes at the time of the patient randomization process. All patients
will be started on our standard immunosupression regimen of prograf/cellcept and a fast
steroid taper. Data will be obtained from every patient for up to one year post-transplant.
Reports of Suspected Thymoglobulin (Anti-Thymocyte Globulin) Side Effects
Febrile Neutropenia (111),
Acute Graft Versus Host Disease in Skin (92),
Acute Graft Versus Host Disease (66),
Cytomegalovirus Test Positive (64),
Chronic Graft Versus Host Disease (45), more >>