Belatacept for Kidney Transplant Immunosuppression
This study is evaluating whether a drug called belatacept may be used to help kidney transplant patients transition to a lower dose of immunosuppressive drugs.
See full descriptionAbout the trial for Kidney Transplant Immunosuppression
Treatment Groups
This trial involves 2 different treatments. Belatacept 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.
About The Treatment
Side Effect Profile for Belatacept
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Kidney Transplant Immunosuppression. There are 7 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Belatacept will improve 1 primary outcome and 7 secondary outcomes in patients with Kidney Transplant Immunosuppression. Measurement will happen over the course of 12 months after the start of immunosuppression wean.
Who is running the study
Principal InvestigatorPatient Q & A Section
How many people get kidney transplant immunosuppression a year in the United States?
As of 2008 there were approximately 1,700,00 patients on renal transplant immunosuppression in the USA. Many patients go through multiple immunosuppressive regimes before deciding to undergo transplant procedure. Therefore, it is not possible to estimate the number of patients on renal transplant immunosuppression.
What causes kidney transplant immunosuppression?
This population-based study demonstrated that patient immunogenicity scores were significant predictors of rejection episodes at one and two yr after renal transplantation. Specific immungenicity scores were not significantly related to early graft function at 2 yr. Results from a recent paper could be used to refine risk factor analyses of immunosuppression among renal transplant recipients.
What are common treatments for kidney transplant immunosuppression?
The most common immunosuppressive regimen in kidney transplantation is MMF+Ceclor+Silybin+ steroids to prevent chronic rejection. The most commonly used cytoadjunctives in early post-transplant rejection regimen are MMF+Ceclor+Silybin+ steroids + tacrolimus. As in general immunosuppressive therapy, other immunosuppressive drugs are also often used for other purposes.
What is kidney transplant immunosuppression?
For many years, the role of CNI-based immunosuppression to prevent rejection and the efficacy of induction protocols were not well understood. Recent studies have shown the relevance of immunosuppressive regimens for maintaining graft and patient survival.
What are the signs of kidney transplant immunosuppression?
The absence of some of the classical signs and symptoms of kidney transplant immunosuppression is likely to be an alerting sign of kidney transplant complications.
Can kidney transplant immunosuppression be cured?
In a recent study, findings shows that the administration of anti-IL-2 and anti-IL-4 monoclonal antibodies in combined regimen for induction does not suppress the anti rejection immunity of the patient. Nevertheless, our study indicates that anti-IL-2 monoclonal antibodies administration after liver transplantation could significantly reduce the occurrence of GVHD for induction, and can help to reduce the dosage and duration of the prophylactic regimen.
What is the average age someone gets kidney transplant immunosuppression?
The average age a child gets organ transplant is 17 months; about 90% of pediatric kidney transplant recipients were not older than 12 years old and received their respective immunosuppression at least 4 years after the pediatric event. Older patients are disproportionately affected, and the average height SLL was the lowest at 24 months in patients older than 13 years. Physicians caring for pediatric transplant patients with high SLLs (>40 ng/ml) should consider earlier initiation of immunosuppressive therapy, and should not consider long-term reduction in intensity when older patients receive organ transplantation.
Is belatacept safe for people?
Belatacept is associated with a low rate of infection but more common non-infectious AEs in people with kidney transplant. Infectious and non-infectious AEs were transient and manageable. The low rate of infection as well as the small rate of adverse events related to belatacept suggest that it is well-matched to the immunosuppressive regimen in these people. The limited amount of people available for long-term analysis may have biased the results.
What is the latest research for kidney transplant immunosuppression?
Both cyclosporin A, tacrolimus, sirolimus and MMF prevent acute rejection. In addition, MMF shows a significant survival benefit when compared with cyclosporin A. Ciclosporin A shows high incidence of drug-related nephrotoxicity. MMF and sirolimus have excellent, though still modest, tolerability and safety profiles.
How serious can kidney transplant immunosuppression be?
Kidney transplant recipients from living kidney donors do not experience posttransplant rejection and rejection-related complications much less frequently than kidney transplant recipients from deceased donors.
What is belatacept?
Belatacept (Enbrel\n) is a novel, selective and potent B cell costimulator and blocker designed to decrease B cell activation and proliferation. The effects on B cell survival, proliferation, and function could result in a decrease of T cell-independent and -dependent tissue injury. Belatacept treatment may have anti-inflammatory properties as well, which may contribute to its efficacy with immunosuppression during organ transplantation. It also has an immunomodulatory effect on dendritic cells (DCs) which express potent regulatory functions. It was approved by the U.S.
How does belatacept work?
Belatacept decreases IFN-γ production and is associated with decreased T cell memory. In fact, the number of IFNs in circulation increases with time on belatacept. Belatacept is associated with T cell proliferation but is not linked to apoptosis. However, the effects of belatacept on CD4 and CD8 T cell function are different. Whereas belatacept improves CD4 T cell responsiveness, it decreases CD8 T cell responses. Belatacept decreases the percentages of T cells that produce TNF-alpha, IFN-gamma, and IL-2, and increases that of IL-10.