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| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | July 3, 2001 | ||||||||||||||||
| Last Updated Date | January 20, 2009 | ||||||||||||||||
| Start Date ICMJE | October 1998 | ||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||
| Change History | Complete list of historical versions of study NCT00018785 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants | ||||||||||||||||
| Official Title ICMJE | Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants | ||||||||||||||||
| Brief Summary | Diabetes and end-stage kidney, liver and heart disease are prominent health issues among veteran patients. Successful solid organ transplantation in the absence of chronic immunosuppressive therapy (specific acquired immunological tolerance) is a desirable therapeutic option. This project extends recent observations supporting the use of concommitant donor bone marrow cell infusion as a means of modulating the immune response in kidney transplantation, thereby allowing a substantial decrease or withdrawal of potentially toxic immunosuppressive drugs. |
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| Detailed Description | |||||||||||||||||
| Study Phase | |||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Design ICMJE | Prevention, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||||||||||
| Condition ICMJE | Kidney Disease | ||||||||||||||||
| Intervention ICMJE | Procedure: donor bone marrow infusion | ||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||
| Publications * | |||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | |||||||||||||||||
| Completion Date | September 2003 | ||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Eligibility Criteria ICMJE | Living related donor kidney transplant recipients and the living related donors. |
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| Gender | Both | ||||||||||||||||
| Ages | |||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT ID ICMJE | NCT00018785 | ||||||||||||||||
| Responsible Party | |||||||||||||||||
| Study ID Numbers ICMJE | IMMU-035-98S | ||||||||||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||||||||||
| Verification Date | December 2004 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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