The Role of B Cells in Kidney Allograft Dysfunction

Transplantation Infection Clinical Trial

Official title:

The Role of B Cells in Kidney Allograft Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294032
• Other study ID #: 5140147
• Secondary ID: GCAT 2014
• Status: Completed
• Start date: August 28, 2014
• Est. completion date: April 24, 2023

Study information

• Verified date: May 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 85 Years

Eligibility

Inclusion Criteria:

• Ability to understand and willingness to sign the written informed consent form (ICF). For pediatric patients, a parent or legal guardian must sign ICF

• Either a Kidney or Liver transplant patient: 1) on the waitlist or 2) transplanted

• Healthy volunteer samples collected to use as the control group for statistical validity

Exclusion Criteria:

• Inability to make all of the required long-term post-transplant visits.

• Females who are pregnant or nursing a child

• Liver patients with hepatitis C virus

Related Conditions & MeSH terms

• Kidney; Complications, Allograft
• Transplantation Infection

Intervention

Drug:
• Immunosuppressive Agents
standard of care for patients post-transplant

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center, Transplantation Institute	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1,3,6,12,18,24,36,48, and 60 months
Secondary	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.	Up to 60 months