An observational study in Kidney; Complications, Allograft and Transplantation Infection, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 2 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by Loma Linda University · Observational
The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune response after kidney transplantation. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.
The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune responses after kidney transplantation. This study aims to address two major challenges in kidney transplantation: 1. to guide physicians when immunosuppressive drugs are weaned, and 2. to identify patients who are at risk or in the process of developing antibody-mediated rejection. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.
Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pediatric and Adult patients who are on the waitlist for a kidney or liver, or are about to undergo kidney or liver transplantation.
Exclusion Criteria:
Patients who are about to undergo a kidney transplant and are on immunosuppressive agents.
Drug: Immunosuppressive Agents
standard of care for patients post-transplant
Also known as: Prograf, Cellcept
Blood collection prior to and after kidney transplantation
Blood will be collected from kidney transplant patients prior to and after their transplant (1-, 3-, 6-, 12-, 18-, 24-, 36-, 48-, and 60- months post-transplant). We will try to better understand the role of specific B-cells after kidney transplant by using enzyme-linked immunosorbent assay (ELISA).
Time frame: 1,3,6,12,18,24,36,48, and 60 months
B cell count
For each patient, we will be measuring the frequency of cells from each B cell subset within the total peripheral blood mononuclear cells (PBMNCs) by MACSQuant cell counts. The distribution of B cells subsets within the total B cell pool will also be determined. Mean Fluorescence Intensity (MFI) of activation markers (CD86 and CD69) on B cells will also be compared across the samples.
Time frame: Up to 60 months
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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