Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01165762|
Recruitment Status : Recruiting
First Posted : July 20, 2010
Last Update Posted : July 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|ESRD||Drug: Immune Tolerance||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion in HLA Haplotype Match Living Donor Kidney Transplantation|
|Actual Study Start Date :||July 14, 2010|
|Estimated Primary Completion Date :||June 14, 2022|
|Estimated Study Completion Date :||June 14, 2024|
Experimental: Immune Tolerance, Kidney transplantation
Induction of immune tolerance in Haplotype matched living donor kidney transplantation.
Drug: Immune Tolerance
Immune tolerance Kidney and hematopoietic cell transplantation with a conditioning regimen of total lymphoid irradiation and antithymocyte globulin followed by immunosuppressive drugs for 18 months. Immunosuppressive drugs are stopped if stable chimerism is achieved and there is no rejection of the transplant kidney.
The IDE used in this study is the column used for hematopoietic cell sorting.
Other Name: Kidney transplantation
- Long term freedom from transplant immunosuppressive drugs, safety, rate of infection, graft survival and patient survival. [ Time Frame: 5 years and indefinitely if possible ]Subjects on study will have tapering of the immunosuppressive medication and withdrawal of the immunosuppressive medication if withdrawal criteria are met.
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): NCT01165762
|Contact: Asha Shori, CCRP||(650) firstname.lastname@example.org|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Asha Shori, CCRP 650-736-0245 email@example.com|
|Principal Investigator: John D Scandling|
|Sub-Investigator: Judith Anne Shizuru|
|Sub-Investigator: Dr. Marc L. Melcher|
|Sub-Investigator: Richard T. Hoppe|
|Sub-Investigator: Robert Lowsky|
|Sub-Investigator: Julie M. Yabu|
|Principal Investigator: Samuel Md Strober|
|Principal Investigator: Stephan Busque|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53792-1690|
|Contact: Dixon Kaufman, MD 608-265-6471 firstname.lastname@example.org|
|Contact: Tommy Boland 608-263-9459 email@example.com|
|Principal Investigator:||Stephan Busque||Stanford University|