Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

10. august 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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).

Studietype

Observasjonsmessig

Registrering (Faktiske)

307

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbeidspartnere

Clinical Trials in Organ Transplantation

Etterforskere

Hovedetterforsker: Michael Abecassis, MD, MBA, Northwestern University
Studiestol: John J Friedewald, MD, Northwestern University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2011

Primær fullføring (Faktiske)

1. juni 2016

Studiet fullført (Faktiske)