HLA-Identical Sibling Renal Transplant Tolerance With Donor Hematopoietic Stem Cells and Campath-1H
Primary Study Objectives:
1. To remove all immunosuppressive therapy from recipients of HLA-identical sibling renal
transplants within 24 months of transplantation.
2. To detect and follow cellular (macro) chimerism of donor hematopoietic stem cell (DHSC)
lineages and the generation of T-regulatory cells using specialized immunomonitoring
assays for these donor/recipient pairs to demonstrate specific immunologic
unresponsiveness.
3. To investigate the safety and efficacy of a treatment regimen consisting of induction
therapy with Campath-1H and steroid-free low dose maintenance immunosuppression,
consisting of mycophenolate mofetil (MMF) and tacrolimus converted to sirolimus. This
is to be followed by complete withdrawal of immunosuppression beginning at one year, at
a minimum, post transplant, in recipients who have also been given four infusions of
purified donor hematopoietic CD34+ stem cells (DHSC).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
The ability to withdraw immunosuppression as above 24 months post-transplant with follow-up to 10 years.
24 months post-transplant with follow-up to 10 years.
No
Joshua Miller, MD
Principal Investigator
Northwestern University
United States: Food and Drug Administration
2R01DK025243-25A2
NCT00619528
July 2007
February 2021
Name | Location |
---|---|
Northwestern Memorial Hospital | Chicago, Illinois 60611 |