Status:
COMPLETED
Paired Marrow Aspirations to Assess Assays in Sensitized Renal Allograft Recipients
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Transplantation, Kidney
Living Donors
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The aim of this study is to determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes.
Detailed Description
The aim of this risk protocol is to determine the variability of the AlloElispot and Allospecificities assay. Our group has developed a number of assays to assess the immune cell population in our tr...
Eligibility Criteria
Inclusion
- Inclusion criteria.
- Pre or post renal transplant recipients.
- Renal transplant donors.
- Those who give voluntary written informed consent before performance of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Exclusion criteria.
- Any patient currently receiving systemic anticoagulation therapy with heparin or coumadin.
- Patient has a platelet count of \<30 x 10(9)/L within 14 days before enrollment.
- Patient has an absolute neutrophil count of ANC\<1.0 x 10(9)/L within 14 days before enrollment.
- Patient has received other investigational drugs within14 days before enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Diagnosed or treated for malignancy within 5 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Contraindication to kidney transplantation or donation-active infection, comorbid medical conditions, etc
Exclusion
Key Trial Info
Start Date :
October 5 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2025
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT01150487
Start Date
October 5 2010
End Date
December 15 2025
Last Update
December 23 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905