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OpenTrials
Completed

NCT Number: NCT02463253

Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients

This is a single-center, prospective, non-randomized, observational study to evaluate specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely monitored over one year after enrollment.

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Key information

Conditions

Delayed Graft Function Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Davis Transplant Center

Sacramento, California, 95817, United States

About this study

OBJECTIVE: The objective of this phase of the study is to allow the clinical site to gain familiarity with patient recruitment, sample and data collection, and interpretation of the proteogenomic biomarker report provided, through retrospective analysis. This phase of the study will provide a platform for the transplant physicians to gain confidence with the format, logistics, and potential use of the biomarker tests on blood and tissue.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients who meet all of the following criteria are eligible for enrollment as study participants:

  • Male and female recipients of all races, ≥18 years of age.
  • Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
  • Subject and/or guardian must be able to provide informed consent.
  • Subject and/or guardian must be able to comply with the study protocol.

Exclusion criteria

  • Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
  • Recipients of previous non-renal solid organ and/or islet cell transplantation
  • Infection with HIV.
  • Inability or unwillingness of a participant and/or guardian to provide informed consent

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Treatment and study plan

Primary outcomes

  1. Biopsy prove acute rejection

    Time frame: 12 months

    Incidence of acute rejection at the time of any kidney biopsy

Secondary outcomes

  1. Gene Expression Profiling

    Time frame: 12 months

    Blood and tissue collection from each subject at the time of each for cause or protocol kidney biopsy

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Northwestern University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
May 25, 2016

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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