Transplantation, Kidney Clinical Trial
Official title:
Paired Bone Marrow Aspirations to Assess the Variability of Allo-ELISPOT and Allo-Specificities Assays in Sensitized Renal Allograft Recipients
Verified date | June 2023 |
Source | Mayo Clinic |
Contact | Nong Yowe Braaten |
Phone | 507-538-9617 |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determine the validity of two tests on bone marrow of sensitized kidney transplant recipients in order to better understand why these patients with antibodies against their donors are at a greater risk of rejection of their transplanted organs.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | April 2030 |
Est. primary completion date | April 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion criteria. - Pre or post renal transplant recipients who are "sensitized", having allo antibodies as evidenced by single antigen bead analysis). - 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of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the variability of the AlloElispot and Allospecificities assay. | Post bone marrow collection |
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