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NCT Number: NCT01289717

Proteogenomic Biomarker Panels in a Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients

There is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. Researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.

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Key information

Conditions

Kidney Transplant Fibrosis Kidney Transplantation Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Division of Nephrology, Phoenix, Arizona, United States

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About this study

Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. One field of interest is how one's cellular make-up might affect the body's immune response (body's natural defense system to illness and foreign things) to a kidney transplant. Cellular tests, like gene expression, help doctors to study a person's cellular traits. Gene expression is when information found in one's DNA is translated into RNA and eventually proteins. These components are present in each of the body's cells. In this study, researchers are trying to learn if certain changes in the RNA and proteins found in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or become too severe. The blood and urine tests will look for patterns in one's DNA (called genetic markers).

This study will follow subjects for 2 years after transplant. There will be a total of 12 study visits with additional study visits if rejection occurs. The study requires additional samples of blood, urine, and tissue to be collected during routine clinical visits and biopsies (a procedure to remove and examine a small piece of kidney tissue).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects undergoing primary or subsequent deceased-donor or living donor kidney transplantation
  • Subject and/or parent guardian must be able to understand and provide informed consent
  • Female subjects of childbearing potential must have a negative pregnancy test within 6 weeks of study entry.

Exclusion criteria

  • Need for combined organ transplantation with an extra-renal organ and/or islet
  • Recipient of previous non-renal solid organ and/or islet cell transplantation
  • Infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

Treatment and study plan

Primary outcomes

  1. Incidence of Biopsy Proven Acute Rejection (AR)-Clinical and Sub-Clinical), Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (CAN/IFTA), and Normal Renal Biopsy with Stable, Good Kidney Function

    Time frame: 12 and 24 months

Secondary outcomes

  1. Incidence of Death

    Time frame: Baseline to month 24

  2. Incidence of Graft Loss

    Time frame: Baseline to month 24

  3. Incidence of Opportunistic infections

    Time frame: Baseline to month 24

  4. Incidence of BKV, CMV, and EBV Infection

    Time frame: Baseline to month 24

  5. Incidence of Treated Urinary Tract Infection

    Time frame: Baseline to month 24

  6. Incidence of Malignancy

    Time frame: Baseline to month 24

  7. Changes that Occur in Blood, Urine, and Kidney Tissue Gene Expression Signature

    Time frame: Month 1 to month 24

  8. Changes in Plasma Protein Expression Profile

    Time frame: Month 1 to month 24

  9. Changes in Urine Protein Expression Profile

    Time frame: Month 1 to month 24

  10. Changes in Blood MicroRNA Expression Profile

    Time frame: Month 1 to month 24

  11. Evolution of Gene and Protein Expression Profiles During Response to Therapy for AR

    Time frame: Month 1 to month 24

  12. Evolution of Gene and Protein Expression Profiles During Progression or Regression of CAN/IFTA on Protocol Biopsies

    Time frame: Month 1 to month 24

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Clinical Trials in Organ Transplantation

Registry information

Official study title

Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients - Transplant Proteogenomics

Acronym: PROGENI-KI

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 4, 2011
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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