The Role of B Cells in Kidney Allograft Dysfunction

NCT02294032 | Completed DMC

• 2 other identifiers: 5140147GCAT 2014
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney; Complications, Allograft; Transplantation Infection

Keywords

Bcells; kidney allograft dysfunction; antibody mediated rejection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• B cell count

  Up to 60 months

Study Arms (1)

Kidney Transplant

Patients who are about to undergo a kidney transplant and are on immunosuppressive agents.

Drug: Immunosuppressive Agents

Interventions

Immunosuppressive Agents DRUG

standard of care for patients post-transplant

Also known as: Prograf, Cellcept

Kidney Transplant

Eligibility Criteria

• Age: 2 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pediatric and Adult patients who are on the waitlist for a kidney or liver, or are about to undergo kidney or liver transplantation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center, Transplantation Institute

Loma Linda, California, 92354, United States

Location

Related Publications (34)

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Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, and plasma or serum

MeSH Terms

Interventions

Immunosuppressive Agents; Tacrolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Michael de Vera, MD, FACS

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: November 19, 2014
• Study Start: August 28, 2014
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)