Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03363945
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2017-11-30
Brief Title:
Cellular Immunotherapy in Recipients of HLA-matched Living Donor Kidney Transplants
Sponsor:
Medeor Therapeutics Inc
Organization:
Medeor Therapeutics Inc
Study Overview
Official Title:
A Phase 3 Randomized Multi-center Open-label Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy With MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched Living Donor Kidney Transplants
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen HLA-matched living donor kidney transplants
Detailed Description:
Currently patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney These medications carry substantial side effects In addition these medicines often do not completely control damage to the kidney from the recipients immune system ultimately causing the kidney to fail
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the recipients immune system to accept a transplanted kidney without the need for long term use of immunosuppression drugs
The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective randomized multicenter clinical trial MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function avert transplant kidney rejection and eliminate the cumulative and serious side effects associated with immunosuppressive drugs
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the recipients immune system to accept a transplanted kidney without the need for long term use of immunosuppression drugs
The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective randomized multicenter clinical trial MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function avert transplant kidney rejection and eliminate the cumulative and serious side effects associated with immunosuppressive drugs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None