| Trial ID: | L1045 |
| Source ID: | NCT05345717
|
| Associated Drug: |
Belatacept Injection
|
| Title: |
Novel Desensitization Kidney Transplantation
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Transplantation|End Stage Kidney Disease (ESRD)
|
| Interventions: |
DRUG: Belatacept Injection
|
| Outcome Measures: |
Primary: Likelihood of finding a donor to whom the study participant does not have strong anti-donor HLA specific antibodies (DSA)., The likelihood of finding a suitable donor will calculated base on calculated Panel of Reactive Antibodies measured 1month after the therapy, 1 year | Secondary: Strong Human Leukocyte Antigen (HLA) antibodies with mean fluorescence intensity (MFI) reduced by more than 50%, A number of strong HLA antibodies with MFI reduced by more than 50% will be counted, 1 year|Time to transplant, Time from the beginning of the implementation of the therapy to kidney transplantation will be measured, 1 year|Episodes of Antibody Mediated Rejection (AMR) and Acute Cellular Rejection (ACR), Number of episodes of AMR and ACR after kidney transplantation will be counted, 1 year|Death, The incidence of episodes of patient death will be calculated, 1 year|Serious infection requiring inpatient intravenous therapies, Incidence rate of the episodes of serious infection requiring inpatient intravenous therapies will be calculated during the study, 1 year|Post-transplant lymphoproliferative disorder, The incidence rate of the episodes of post-transplant lymphoproliferative disorder will be calculated, 1 year
|
| Sponsor/Collaborators: |
Sponsor: University of Chicago
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
5
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-05-01
|
| Completion Date: |
2026-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-04
|
| Locations: |
University of Chicago, Chicago, Illinois, 60637, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05345717
|
