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An In-vitro Standardization of B Cell Elispot Assays

NCT01334281 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2013-04-22

No results posted yet for this study

Summary

This study is being done because the study doctor is trying to develop a new test which will help transplant doctors monitor patients with high panel reactive antibodies (PRA). The test would be used to monitor patients' PRA when doctors are trying to lower it through a process known as desensitization. Desensitization lowers high PRA levels and allows patients to receive transplants. This is a single center study to evaluate and optimize the use of a new laboratory test to detect and measure the immune system's functioning.

Conditions

  • Transplant Sensitization
  • Panel Reactive Antibody
  • Sensitization to HLA Antigens

Interventions

PROCEDURE

Blood Draw

Three tubes of blood will be drawn (three 10ml-green top), 7 times (total of 210 ml for study) at the indicated time points: 1) enrollment, 2) anticipated midpoint of desensitization, 3) prior to transplant, 4) three months post-transplant, 5) six months post-transplant, 6) 12 months post-transplant, and 7) 24 months post-transplant.

PROCEDURE

Blood Draw

Three tubes of blood will be drawn (three 10ml-green top) twice (60 ml total for study), 8-12 weeks apart. Can be drawn during clinic visit or separate standard of care dialysis visit.

Sponsors & Collaborators

Principal Investigators

  • Anat Tambur, DMD, PhD · Northwestern University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-04-30
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01334281 on ClinicalTrials.gov