Assessing immune profiles in kidney transplant recipients and donors
Paired Bone Marrow Aspirations to Assess the Variability of Allo-ELISPOT and Allo-Specificities Assays in Sensitized Renal Allograft Recipients
This study is trying to understand the immune system of kidney transplant patients and their donors by looking at their immune cells to see how they respond to the transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT01150487 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the immune cell compositions in the bone marrow and lymph nodes of kidney transplant recipients and their donors. It involves paired marrow aspirations to assess various immune assays, including the AlloELISPOT and Allospecificities assays, which measure donor-specific alloantibody production. The research focuses on characterizing plasma cells and their functions, as well as analyzing T and B-cell diversity using advanced techniques like flow cytometry and mass spectrometry. The goal is to validate these assays to improve the understanding of immune responses in transplant patients.
Who should consider this trial
Good fit: Ideal candidates include pre or post renal transplant recipients and renal transplant donors who can provide informed consent.
Not a fit: Patients currently on systemic anticoagulation therapy or with certain blood count abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing immune responses in kidney transplant recipients, potentially enhancing transplant outcomes.
How similar studies have performed: Other studies have shown promise in assessing immune profiles in transplant populations, but this specific approach is novel in its comprehensive assessment of plasma cells and immune assays.
Eligibility criteria
Show full inclusion / exclusion criteria
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of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Mark Stegall, MD — Mayo Clinic
- Study coordinator: Nong Yowe Braaten
- Phone: 507-538-9617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.