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Personalization of Immunosuppressive Treatment for Organ Transplant Recipients

NCT05747053 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2024-02-26

No results posted yet for this study

Summary

Long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. While rates of acute rejection (AR) continue to decrease, it remains the strongest predictor of long-term allograft survival, and so having a better understanding of factors predicting AR may contribute to more individualized patient care. Selecting optimum immunosuppressive dosage is another factor in personalizing kidney care. This project will study two areas of individualized kidney care: 1) assessing rejection by surveillance testing utilizing AlloSure, 2) developing an algorithm to select optimum immunosuppressive medication dosage.

Conditions

  • Kidney Injury
  • Kidney Failure
  • Kidney Failure, Chronic
  • Kidney Failure, Acute
  • Kidney Diseases
  • Kidney Transplant Rejection
  • Kidney Transplant Infection
  • Kidney Transplant; Complications
  • Kidney Disease, Chronic
  • Kidney Ischemia

Interventions

DIAGNOSTIC_TEST

AlloSure

AlloSure blood-draw at Post-operation day one and four, as well as one month, 2 months, 3, 9, 12, 15,18 and 24 months operation.

DIAGNOSTIC_TEST

PAXGene

1 PAXgene tube will be collected with every biopsy performed and sent with the AlloSure test for the second 100 patients (patients 101-200). 21 gene markers will be sequenced by collecting 3 ml of blood.

Sponsors & Collaborators

  • CareDx

    collaborator INDUSTRY

  • VirginiaBio Analytics, LLC

    collaborator UNKNOWN

  • George Washington University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-12-08
Completion
2022-12-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05747053 on ClinicalTrials.gov