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

10 augusti 2017 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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).

Studietyp

Observationell

Inskrivning (Faktisk)

307

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Adults undergoing kidney transplantation.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: Kohort
Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått	Tidsram
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 Tidsram: 12 and 24 months	12 and 24 months

Sekundära resultatmått

Resultatmått	Tidsram
Incidence of Death Tidsram: Baseline to month 24	Baseline to month 24
Incidence of Graft Loss Tidsram: Baseline to month 24	Baseline to month 24
Incidence of Opportunistic infections Tidsram: Baseline to month 24	Baseline to month 24
Incidence of BKV, CMV, and EBV Infection Tidsram: Baseline to month 24	Baseline to month 24
Incidence of Treated Urinary Tract Infection Tidsram: Baseline to month 24	Baseline to month 24
Incidence of Malignancy Tidsram: Baseline to month 24	Baseline to month 24
Changes that Occur in Blood, Urine, and Kidney Tissue Gene Expression Signature Tidsram: Month 1 to month 24	Month 1 to month 24
Changes in Plasma Protein Expression Profile Tidsram: Month 1 to month 24	Month 1 to month 24
Changes in Urine Protein Expression Profile Tidsram: Month 1 to month 24	Month 1 to month 24
Changes in Blood MicroRNA Expression Profile Tidsram: Month 1 to month 24	Month 1 to month 24
Evolution of Gene and Protein Expression Profiles During Response to Therapy for AR Tidsram: 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 Tidsram: Month 1 to month 24	Month 1 to month 24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbetspartners

Clinical Trials in Organ Transplantation

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2011

Primärt slutförande (Faktisk)

1 juni 2016

Avslutad studie (Faktisk)