Paired Marrow Aspirations to Assess Assays in Sensitized Renal Allograft Recipients

NCT01150487 | Completed DMC

• 2 other identifiers: 10-002572R21AI125719
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplantation, Kidney; Living Donors; Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• To determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes.

  1 week Post bone marrow and lymph node collection.

Study Arms (1)

Kidney recipients or kidney donors

EXPERIMENTAL

Patients who have had a Kidney transplant or are undergoing a kidney transplant. Kidney donors.

Procedure: bone marrow aspirations; Procedure: lymph node collection

Interventions

bone marrow aspirations PROCEDURE

A bone marrow aspiration from each hip bone of the patients.

Kidney recipients or kidney donors

lymph node collection PROCEDURE

An Iliac lymph node collection.

Kidney recipients or kidney donors

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Mark Stegall, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 25, 2010
• Study Start: October 5, 2010
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)