CLINICAL TRIAL

Belatacept for Kidney Transplant Immunosuppression

Newly Diagnosed
Recruiting · 18+ · All Sexes · Dallas, TX

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.

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About 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Belatacept
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belatacept
FDA approved

Side Effect Profile for Belatacept

Belatacept
Show all side effects
67%
COPD exacerbation
COPD exacerbation
67%
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT02078193) in the Belatacept ARM group. Side effects include: COPD exacerbation with 67%.

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Stable renal function (eGFR>40mL/min for 3 months prior to enrollment)
Adult (>18 years) recipients of a kidney-only transplant, including re-transplants
Non-HLA identical Living or Deceased Donor Grafts
Able to provide informed consent
Absence of donor specific antigens
Patients treated with Belatacept as part of de novo immunosuppression or converted to Belatacept with stable kidney function for 3 months (as stated above)
Patients who underwent kidney transplantation at least 9 months prior to study entry
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months after the start of immunosuppression wean
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months after the start of immunosuppression wean
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months after the start of immunosuppression wean.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Number of participants with appearance of de-novo donor specific antibodies (dnDSA)
12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
HLA type I and type II in blood will be used to detect the presence of de-novo donor specific antibodies (dnDSA)
12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
Negative predictable value as measured by AlloMap®
12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
Negative predictable value measured by AlloMap®, expressed as a percent, that the patient is not experiencing rejection at the time of testing. AlloMap® is a panel of 20 gene assays, 11 informative and 9 used for normalization and/or quality control, which produces gene expression data used in the calculation of an AlloMap test score - an integer ranging from 0 to 40. Compared with patients in the same post- transplant period, the lower the score, the lower the probability of acute cellular rejection at the time of testing.
12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
Number of patients with kidney graft failure
12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
Incidence of kidney graft failure will be measured from the start of immunosuppresion wean until 12 months after. Graft failure is defined as date of patient death or date of retransplant
12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
Number of participants with Proteinuria
12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
Proteinuria will be detected by a semiquantitative method of the protein concentration in urine.
12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
Number of patients with acute kidney graft rejection
12 MONTHS AFTER THE DATE OF THE FIRST IMMUNOSUPPRESSION TAPER
Number of patients with Acute kidney graft rejection confirmed by biopsy by 2017 Banff Criteria. Incidence of biopsy proven acute kidney graft rejection at 12 months after the start of immunosuppression taper
12 MONTHS AFTER THE DATE OF THE FIRST IMMUNOSUPPRESSION TAPER
Mean change in Estimated Glomerular Filtration Rate (eGFR)
BASELINE, 12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
Estimated glomerular filtration rate (eGFR) in blood will be measured at the beginning of enrollment and the difference will be measured to the end of the study as a measure of change in kidney function.
BASELINE, 12 MONTHS AFTER THE START OF IMMUNOSUPPRESSION WEAN
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Who is running the study

Principal Investigator
D. W.
David Wojciechowski, Medical Director of the Kidney Transplantation Program
University of Texas Southwestern Medical Center

Patient Q & A Section

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

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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