Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] for Kidney Transplantation

3
Effectiveness
3
Safety
The Christ Hospital, Cincinnati, OH
+1 More
Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] - Drug
Eligibility
18+
All Sexes
Eligible conditions
Kidney Transplantation

Study Summary

This study is evaluating whether a combination of medications may help prevent rejection of a kidney transplant.

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Eligible Conditions

  • Kidney Transplantation
  • Immunosuppression

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] will improve 1 primary outcome in patients with Kidney Transplantation. Measurement will happen over the course of 12 months.

12 months
Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Comparator arm
Prospective Arm

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Prospective ArmDe novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Once-daily tacrolimus XR 0.8mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 24-hr trough levels of 8-12ng/mL up to day 30 followed by 24-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery
Comparator armHistorical control arm consisting of the following De novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Twice-daily tacrolimus 0.1mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 12-hr trough levels of 8-12ng/mL up to day 30 followed by 12-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Mycophenolate mofetil
FDA approved
Methylprednisolone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

The Christ Hospital - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Kidney Transplantation or the other condition listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male and female patients ≥ 18 years of age.
Patient who is receiving a renal transplant from a living or heart-beating deceased donor.
Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
The patient has given written informed consent to participate in the study

Patient Q&A Section

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

What are the signs of immunosuppression?

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Results from a recent paper, the signs presented with the occurrence of SOT are fever and increased white blood cell count. There are no specific signs of immunosuppression.

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Can immunosuppression be cured?

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Recent findings suggest that many cases of immune failure may be cured with corticosteroid withdrawal. These patients may need close monitoring by immuno-metabolic team following the therapeutic intervention.

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What is immunosuppression?

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There are many definitions of immunosuppression. The most common use is to describe patients on a treatment who are in a prolonged state of cellular or humoral immunosuppression, as in organ or stem cell transplanted patient populations. For a more accurate definition of the term 'immunosuppression', it is necessary to consider patient-specific immunogenetic and cytokine profiles. It is important to recognize the dynamic nature of transplant rejection processes and the need to adopt the appropriate timing of rejection therapy, at which immunosuppressive drugs are withdrawn.

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What causes immunosuppression?

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Immune dysfunction in transplant patients likely reflects a combination of infection or medication-associated immunosuppression and other factors, including genetic predisposition. The immunological alterations that occur in transplant transplant patients may be a mechanism for the risk of CMV disease despite current and ongoing medication regimens.

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What are common treatments for immunosuppression?

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The following have been used to treat immunosuppression:\n- antihistamines to prevent drug hypersensitivity\n- anticonvulsants to prevent or treat seizures\n- corticosteroids to relieve symptoms\n- antibiotics to prevent or treat an infectious disorder\n- dialysis to correct an electrolyte imbalance or remove toxins or solutes from the blood.\n\n- Allergy: antihistamines can prevent allergic reactions in the first place for allergic individuals, and often prevent asthma sufferers from needing to use nonsteroidal anti-inflammatory drugs (NSAIDs) to control symptoms.

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How many people get immunosuppression a year in the United States?

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Approximately 18 million people in the United States use some sort of immunosuppressive drugs at some point in time. The use of these drugs is growing with the passage of time. However, the use of immunosuppressive agents is still far less than the prevalence of various malignancies we wish to prevent.

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What are the common side effects of rabbit anti-human t-lymphocyte globulin injectable solution [thymoglobulin]?

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There was no reported correlation between clinical variables and detectable serum levels. There was no treatment-related toxicity or side effects. Thymoglobulin induces transient elevation of liver enzymes and decreases platelet counts when it is administered before bone marrow donation. We did not observe any other side effect during the administration of the drug.

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What are the latest developments in rabbit anti-human t-lymphocyte globulin injectable solution [thymoglobulin] for therapeutic use?

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ThymoGlobulin-based therapy represents a novel and efficacious modality, in particular in the treatment of autoimmune thrombocytopenic purpura, multiple myeloma, and autoallergy. In fact, the use of ThymoGlobulin is widely recognized due to the high safety profile, ease of use, and low occurrence of side-effects. Moreover, the lack of occurrence of progressive autoimmune side effects observed after the use of Thymoglobulin in humans has been already demonstrated in rabbit models.

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Have there been any new discoveries for treating immunosuppression?

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Immunosuppressive drugs are the most widely used agents for treating all types of immunodeficiency; however, their risks prohibit these medications as an option in all situations due to their side effects. There is a lack of treatments that have been found to be more effective than currently available medications. [Power(http://www.withpower.com/immunosuppression)]. However, there has been an introduction of a whole number of new therapies that have been developed to treat immunosuppression, such as rituximab, a monoclonal antibody that binds to and kills B cells.

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What is rabbit anti-human t-lymphocyte globulin injectable solution [thymoglobulin]?

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Thymoglobulin can be administered subcutaneously. Clinical effects appear to be comparable to that reported from randomized controlled trials of intrathecal administration. As a consequence of the short intrathecal exposure of T lymphocytes, a higher relapse rate in the intrathecal group, and the transient nature of the clinical effects, thymoglobulin appears better suited to intravenous administration than intrathecal administration. The safety of thymoglobulin and the potential impact of the intrathecal administration of thymoglobulin on clinical outcomes in patients with hematological malignancies and multiple sclerosis are both worthy of ongoing investigation.

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What does rabbit anti-human t-lymphocyte globulin injectable solution [thymoglobulin] usually treat?

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To my knowledge this is the first paper to use the WHO categorization of T cell lymphoproliferative diseases, to apply thymoglobulin, and to publish the clinical results of the immunotherapeutic treatment, but I must mention that this kind of treatment, if given during the time of exacerbation of SLE, has previously given good results in the reduction of flares and relapses of the patient in a short time. The therapy for SLE should be chosen after the exclusion of other severe diseases affecting the immune system, as the disease is related to immunosuppression.

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Who should consider clinical trials for immunosuppression?

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Patients with no prior transplantation or no history of clinical rejection or allograft nephropathy should consider clinical trial enrollment. Those with prior transplantation who would be candidates for renal transplantation or who have experienced a prior episode of acute rejection or transplant nephropathy would be appropriate candidates for a clinical trial of immunosuppressive treatment.

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