This trial is evaluating whether belatacept will improve 2 primary outcomes and 14 secondary outcomes in patients with Highly Sensitized Prospective Kidney Transplant Recipients. Measurement will happen over the course of Baseline (Visit 0) to Week 20 post treatment initiation.
This trial requires 15 total participants across 2 different treatment groups
This trial involves 2 different treatments. Belatacept is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
"The presence of class IV anti-class I antibodies is an independent predictor of immediate graft loss and increased incidence of acute rejection in highly sensitized recipients." - Anonymous Online Contributor
"We identified a significant risk of delayed graft function in highly sensitized recipients with ESRD. The main risk factors were pretransplant DSA and HLA class I positivity. Further study with a prospective design is needed to define the optimum HLA class II matching for these patients to reduce the incidence of DGF." - Anonymous Online Contributor
"Highly sensitized recipients had a higher risk of having a history of exposure to the medications in question but this was not seen for highly sensitized recipients who were not exposed to this drug class. The role of the other drugs and their interactions cannot be excluded." - Anonymous Online Contributor
"The number of patients with HSP is growing and may be expected to grow. The high numbers of HSP, especially in men, could have adverse clinical consequences. HSP could represent a potential risk for patients who have recently participated in a kidney transplant." - Anonymous Online Contributor
"Patients with highly sensitized (i.e. with a donor serum-level >3.0 units/L or >20 mm (mg/ml)) are at elevated risk of acute rejection and development of chronic antibody-mediated rejection which is difficult to treat. Early ciclosporin A-based immunosuppression combined with the use of HLA-mismatched living donor-human-lethals may be effective (i.e. reduction of the need for steroid bolus) but this regimen remains relatively uncommon and, where available, not always tolerated. Findings from a recent study should inform the medical management program of any renal transplantation in highly sensitized patients." - Anonymous Online Contributor
"This prospective study demonstrates that high HSA levels, although associated with a higher incidence of rejection, do not confer additional risk to the long-term survival of highly sensitized patients, when managed by the standard steroid-based immunosuppressive regimen." - Anonymous Online Contributor
"Belatacept is generally well tolerated, with low discontinuation rates in a high risk patient population. Belatacept should be considered for treatment of end stage kidney disease in adults with high risk HLA seropositive patients. Given its efficacy and safety profile it warrants further investigation in a larger patient population. Clinicaltrials.gov NCT02806048." - Anonymous Online Contributor
"Patients with sHCA have a considerable risk of posttransplant complications. A history of HCA, in conjunction with the panel assay, is a highly prognostically significant variable. In highly sensitized patients with two HCA, graft survival after living donor/living-related-donor kidney transplantation is comparable with that in patients without HCA on their recipients' systems." - Anonymous Online Contributor
"Belatacept was associated with improvements in QoL and clinical response rates of HS patients in the first 6 months of treatment. These improvements are most likely attributed to belatacept exposure and early patient monitoring rather than belatacept treatment itself." - Anonymous Online Contributor
"Because HT was common, especially in patients who presented with HLA class I (HLA-01) mismatching, HLA-class I mismatching itself can be an independent factor contributing to HT of HSPKTR." - Anonymous Online Contributor
"A high risk of serious adverse events does not exist in belatacept-treated patients. All AEs reported herein were of grade 1 or grade 2. No AEs or deaths were considered to be drug-related. Recent findings has demonstrated the safety and tolerability of belatacept therapy when used to prevent rejection in high-risk kidney transplant recipients." - Anonymous Online Contributor
"Current treatment of HSPRT includes triple immunosuppressive regimens and anti-CD154 agents without major differences in overall outcome. The use of anti-CD154 agents decreases the incidence of AR and acute rejection episodes, and thereby promotes long-term patient and graft survival." - Anonymous Online Contributor