Trials / Completed
CompletedNCT00001858
Monitoring for Tolerance to Kidney or Combined Kidney-Pancreas Transplants
Monitoring for Donor-Specific Hyporesponsiveness Following Renal and Pancreatic Allotransplantation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 294 (actual)
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This protocol facilitates the development of methods for determining whether transplant recipients have developed immune hyporesponsiveness or tolerance towards their allograft. These methods will involve the study of peripheral blood or biopsy tissue obtained at regular intervals from patients receiving kidney or combined kidney-pancreas allografts at the Warren G. Magnuson Clinical Center. In addition, patients that have previously received a kidney or combined kidney-pancreas allograft will be evaluated using assays requiring peripheral blood mononuclear cells and/or biopsies. Assays developed under this protocol will be used in subsequent protocols to assess the effects of immune modulating treatment regimens and may eventually be used to direct clinical care or guide the withdrawal of immunosuppressive agents. However, patients enrolled in this protocol will not have any change in treatment based solely on the assays developed without being enrolled in an additional study.
Detailed description
This protocol facilitates the development of methods for determining whether transplant recipients have developed immune hyporesponsiveness or tolerance towards their allograft. These methods will involve the study of peripheral blood or biopsy tissue obtained at regular intervals from patients receiving kidney or combined kidney-pancreas allografts at the Warren G. Magnuson Clinical Center. In addition, patients that have previously received a kidney or combined kidney-pancreas allograft will be evaluated using assays requiring peripheral blood mononuclear cells and/or biopsies. Assays developed under this protocol will be used in subsequent protocols to assess the effects of immune modulating treatment regimens and may eventually be used to direct clinical care or guide the withdrawal of immunosuppressive agents. However, patients enrolled in this protocol will not have any change in treatment based solely on the assays developed without being enrolled in an additional study.
Conditions
Timeline
- Start date
- 1999-06-08
- Completion
- 2014-05-30
- First posted
- 1999-11-04
- Last updated
- 2019-12-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00001858. Inclusion in this directory is not an endorsement.