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Sponsors and Collaborators: |
Northwestern University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00619528 |
The purpose of this study is to attempt to eliminate the necessity of immunosuppressive therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor hematopoietic stem cell (DHSC) lineages for pairs to demonstrate immunologic unresponsiveness, and to investigate the safety and efficacy of the treatment regimen including withdrawal of immunosuppression after one year post-transplant for those recipients having received DHSC infusions.
Condition | Intervention |
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Immunosuppression Kidney Transplantation Graft Rejection |
Procedure: Infusion of Donor Hematopoietic Stem Cells and Campath-1H |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Factorial Assignment, Efficacy Study |
Official Title: | HLA-Identical Sibling Renal Transplant Tolerance With Donor Hematopoietic Stem Cells and Campath-1H |
Estimated Enrollment: | 20 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
No separate arms: All Enrolled Receive Same Treatment
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Procedure: 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) Tacro/Siro and MMF therapy will result in a high degree of macrochimerism (>10%), and a robust prolonged donor-specific (post-thymic) immunoregulatory condition that will allow renal transplant survival in the absence of permanent immunosuppression.
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Primary Study Objectives:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joshua Miller, MD | (312) 503-1801 | joshuamiller@northwestern.edu |
Contact: Anne Rosen, BSN RN CCRC | (312) 503-0444 | arosen@northwestern.edu |
United States, Illinois | |
Northwestern Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60611 | |
Principal Investigator: Joshua Miller, MD | |
Sub-Investigator: Joseph Leventhal, MD | |
Sub-Investigator: James Mathew, PhD | |
Sub-Investigator: Michael Abecassis, MD | |
Sub-Investigator: Richard Burt, MD | |
Sub-Investigator: Lorenzo Gallon, MD | |
Sub-Investigator: Charles Goolsby, PhD | |
Sub-Investigator: Yashpal Kanwar, MD | |
Sub-Investigator: Dixon Kaufman, MD, PhD | |
Sub-Investigator: Anat Tambur, DMD, PhD |
Principal Investigator: | Joshua Miller, MD | Northwestern University |
Responsible Party: | Northwestern University ( Joshua Miller, MD - Principal Investigator ) |
Study ID Numbers: | 2R01DK025243-25A2, R01DK025243 |
Study First Received: | February 8, 2008 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00619528 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Transplants Kidney Transplantation Immunosuppression |
HLA Antigens Stem Cells Bone Marrow |
Alemtuzumab |
Antineoplastic Agents Therapeutic Uses Alemtuzumab Pharmacologic Actions |