HLA-Identical Sibling Renal Transplant Tolerance
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|ClinicalTrials.gov Identifier: NCT00619528|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2008
Last Update Posted : October 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Immunosuppression Kidney Transplantation Graft Rejection||Biological: Infusion of Donor Hematopoietic Stem Cells and Campath-1H||Not Applicable|
Primary Study Objectives:
- To remove all immunosuppressive therapy from recipients of HLA-identical sibling renal transplants within 24 months of transplantation.
- 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.
- 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 Cluster of Differentiation (CD)34+ stem cells (DHSC).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||HLA-Identical Sibling Renal Transplant Tolerance With Donor Hematopoietic Stem Cells and Campath-1H|
|Study Start Date :||July 2007|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2021|
No separate arms: All Enrolled Receive Same Treatment
Biological: Infusion of Donor Hematopoietic Stem Cells and Campath-1H
Intervention: a four-dose (peri-operative and 3, 6, and 9-month boost) DHSC infusion protocol using two-dose Campath-1H induction combined with transient (conditioning) Tacrolimus/Sirolimus and MMF therapy will result in a high degree of macro-chimerism (>10%), and a robust prolonged donor-specific (post-thymic) immunoregulatory condition that will allow renal transplant survival in the absence of permanent immunosuppression.
- The ability to withdraw immunosuppression as above 24 months post-transplant with follow-up to 10 years. [ Time Frame: 24 months post-transplant with follow-up to 10 years. ]
- Patient and graft survival measured at the one-year timepoint post-transplant. [ Time Frame: One Year ]
- Patient and graft survival measured at the three year timepoint post-transplant.. [ Time Frame: Three years post-transplant. ]
- Incidence rate of biopsy-proven acute rejection, defined as a renal biopsy demonstrating acute cellular or humoral rejection of Banff Grade IA or greater. [ Time Frame: Up to 5 years Post-Transplant ]
- Incidence of chronic allograft nephropathy, determined using renal biopsies and laboratory values, including 24 hour urine protein excretion. [ Time Frame: Up to 5 years post transplant ]
- Incidence of graft versus host disease (GVHD). [ Time Frame: Up to 5 years Post-Transplant ]
- Incidence of adverse events associated w/ renal transplantation and immunosuppression, including infections, malignancies, post transplant lymphoproliferative disease (PTLD), thromboembolic events, hyperlipidemia, leukopenia, thrombocytopenia, GI toxic [ Time Frame: Up to 5 years Post-Transplant ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619528
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Joshua Miller, MD||Northwestern University|