Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04827186 |
| Other study ID # |
2021-0286 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 26, 2021 |
| Est. completion date |
April 1, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
University of Illinois at Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Although the notions that kidney transplantation is the treatment of choice for patients with
end-stage renal disease and that simultaneous kidney and pancreas transplant is the only
treatment able to restore euglycemia in patients with type 1 diabetes and selected patients
with type 2 diabetes, are now consolidated, rates of transplantation remain low among
potential candidates with high levels of preformed anti-HLA antibodies. Most of the data
comes from the experience in kidney transplant but can be easily translated to pancreas
transplant.
Approximately 30% of patients on the transplant waiting list have evidence of sensitization
in the form of alloantibodies, generated from exposure to previous transplants, blood
transfusions, pregnancy, or other events. The presence of a panel-reactive antibody level of
at least 80% (i.e. a high level of sensitization) creates difficulty in finding matched
kidneys from compatible donors, leading to lower rates of transplantation in highly
sensitized candidates compared to non-sensitized; the longer waiting times translates in an
increased mortality rate. Despite the development of desensitization strategies and the
advancement in immunosuppression protocols, it is apparent that transplanting these patients
carries an increased risk of acute antibody mediated rejection; 25%-50% of transplants will
have an early acute antibody mediated rejection . Most of these rejections can be
successfully treated, but a high rate of transplant glomerulopathy and chronic antibody
mediated rejection (AMR) leading to accelerated allograft failure is common.
Description:
Although the notions that kidney transplantation is the treatment of choice for patients with
end-stage renal disease and that simultaneous kidney and pancreas transplant is the only
treatment able to restore euglycemia in patients with type 1 diabetes and selected patients
with type 2 diabetes, are now consolidated, rates of transplantation remain low among
potential candidates with high levels of preformed anti-HLA antibodies. Most of the data
comes from the experience in kidney transplant but can be easily translated to pancreas
transplant.
Approximately 30% of patients on the transplant waiting list have evidence of sensitization
in the form of alloantibodies, generated from exposure to previous transplants, blood
transfusions, pregnancy, or other events. The presence of a panel-reactive antibody level of
at least 80% (i.e. a high level of sensitization) creates difficulty in finding matched
kidneys from compatible donors, leading to lower rates of transplantation in highly
sensitized candidates compared to non-sensitized; the longer waiting times translates in an
increased mortality rate. Despite the development of desensitization strategies and the
advancement in immunosuppression protocols, it is apparent that transplanting these patients
carries an increased risk of acute antibody mediated rejection; 25%-50% of transplants will
have an early acute antibody mediated rejection . Most of these rejections can be
successfully treated, but a high rate of transplant glomerulopathy and chronic antibody
mediated rejection (AMR) leading to accelerated allograft failure is common.
This protocol has been designed to demonstrate the feasibility and efficacy of spleen
transplant as a desensitization strategy for highly sensitized patients, potential candidates
of kidney or simultaneous kidney pancreas transplant with (positive cross-match by flow
cytometry (T or B) or B positive standard cross-match). After obtaining surgical and research
consent at a pre-transplant clinic visit, patients will be receiving spleen transplant
followed by spleen removal and kidney or simultaneous kidney pancreas transplant. Duration of
the subject participation will begin upon consent and will last for one year after the
surgery.
Incidence of treated acute rejection (humoral or cellulo-mediated) within the first year
(defined as biopsy proven or clinically indicated) will be determined. Graft and patient
survival will be monitored and compared with a cohort of highly sensitized patients with
similar immunological characteristics, treated with our standard protocol. DSA levels and
post-transplant cross-match will be determined.
