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Proteogenomic Biomarker Panels in a Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients (PROGENI-KI)

10. august 2017 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

307

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85054
        • Mayo Clinic, Division of Nephrology
    • California
      • La Jolla, California, Forenede Stater, 92037
        • The Scripps Research Institute, Scripps Center for Organ and Cell Transplantation,
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University, Feinberg School of Medicine, Division of Organ Transplantation
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • The Cleveland Clinic
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina, Division of Transplant

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Adults undergoing kidney transplantation.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 12 and 24 months
12 and 24 months

Sekundære resultatmål

Resultatmål
Tidsramme
Incidence of Death
Tidsramme: Baseline to month 24
Baseline to month 24
Incidence of Graft Loss
Tidsramme: Baseline to month 24
Baseline to month 24
Incidence of Opportunistic infections
Tidsramme: Baseline to month 24
Baseline to month 24
Incidence of BKV, CMV, and EBV Infection
Tidsramme: Baseline to month 24
Baseline to month 24
Incidence of Treated Urinary Tract Infection
Tidsramme: Baseline to month 24
Baseline to month 24
Incidence of Malignancy
Tidsramme: Baseline to month 24
Baseline to month 24
Changes that Occur in Blood, Urine, and Kidney Tissue Gene Expression Signature
Tidsramme: Month 1 to month 24
Month 1 to month 24
Changes in Plasma Protein Expression Profile
Tidsramme: Month 1 to month 24
Month 1 to month 24
Changes in Urine Protein Expression Profile
Tidsramme: Month 1 to month 24
Month 1 to month 24
Changes in Blood MicroRNA Expression Profile
Tidsramme: Month 1 to month 24
Month 1 to month 24
Evolution of Gene and Protein Expression Profiles During Response to Therapy for AR
Tidsramme: Month 1 to month 24
Month 1 to month 24
Evolution of Gene and Protein Expression Profiles During Progression or Regression of CAN/IFTA on Protocol Biopsies
Tidsramme: Month 1 to month 24
Month 1 to month 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Clinical Trials in Organ Transplantation

Efterforskere

  • Ledende efterforsker: Michael Abecassis, MD, MBA, Northwestern University
  • Studiestol: John J Friedewald, MD, Northwestern University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2011

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

2. februar 2011

Først indsendt, der opfyldte QC-kriterier

2. februar 2011

Først opslået (Skøn)

4. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • DAIT CTOT-08

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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