Ignite Creation Date:
2024-05-06 @ 8:18 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02711826
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2016-03-11
Brief Title:
Treg Therapy in Subclinical Inflammation in Kidney Transplantation
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation CTOT-21
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TASK
Brief Summary:
The purpose of this study is
To see if polyTregs can reduce inflammation in a transplanted kidney
To find out what effects good or bad polyTregs will have in the kidney recipient
To find out what effects good or bad taking everolimus after polyTregs will have in the kidney recipient
To see if polyTregs can reduce inflammation in a transplanted kidney
To find out what effects good or bad polyTregs will have in the kidney recipient
To find out what effects good or bad taking everolimus after polyTregs will have in the kidney recipient
Detailed Description:
Inflammation occurs when the bodys defense system recognizes a foreign object such as a transplanted kidney and responds by sending white blood cells to attack the foreign object These cells and the substances they produce can damage the transplanted kidney There is currently no standard treatment for inflammation in the kidney some transplant centers do not treat inflammation at all Rejection is a more severe form of inflammation and injury Both inflammation and rejection are diagnosed by looking at a piece of kidney a kidney biopsy under a microscope Kidneys that have inflammation andor rejection do not work as well or last as long as kidneys without injury
People who have a transplant take immunosuppressive drugs IS to prevent inflammation and rejection Although kidney transplant recipients usually do well in the first five years after transplant transplant researchers are interested in finding ways to prevent inflammation and rejection without IS or with lower doses of IS in order to avoid side effects
While some white blood cells cause inflammation other types of white blood cells called T regulatory cells Tregs can control inflammation Tregs may have an important role in controlling or preventing inflammation and rejection A persons Tregs can be grown in the laboratory to increase their number polyTreg These Tregs can be given back through a needle placed in a vein IV PolyTregs when given to the recipient might reduce inflammation in the transplanted kidney However this effect has not yet been shown
One of the IS drugs used in kidney transplant is Everolimus Everolimus has been shown to help Tregs survive better than other types of IS drugs
This is a randomized open-label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with subclinical inflammation SCI in the 3 to 7 months post-transplant allograft protocol biopsy compared to control patients treated with CNI-based immunosuppression The efficacy of the Treg therapy will be assessed by the reduction of graft inflammation on biopsies performed at 7 months after study group allocation compared to the eligibility biopsy
People who have a transplant take immunosuppressive drugs IS to prevent inflammation and rejection Although kidney transplant recipients usually do well in the first five years after transplant transplant researchers are interested in finding ways to prevent inflammation and rejection without IS or with lower doses of IS in order to avoid side effects
While some white blood cells cause inflammation other types of white blood cells called T regulatory cells Tregs can control inflammation Tregs may have an important role in controlling or preventing inflammation and rejection A persons Tregs can be grown in the laboratory to increase their number polyTreg These Tregs can be given back through a needle placed in a vein IV PolyTregs when given to the recipient might reduce inflammation in the transplanted kidney However this effect has not yet been shown
One of the IS drugs used in kidney transplant is Everolimus Everolimus has been shown to help Tregs survive better than other types of IS drugs
This is a randomized open-label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with subclinical inflammation SCI in the 3 to 7 months post-transplant allograft protocol biopsy compared to control patients treated with CNI-based immunosuppression The efficacy of the Treg therapy will be assessed by the reduction of graft inflammation on biopsies performed at 7 months after study group allocation compared to the eligibility biopsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None