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

Associating Renal Transplantation With the ITN Signature of Tolerance (ARTIST)

An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)

This is an observational study for people who have received a kidney transplant within the past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and cells in the blood that has been found in a group of rare transplant patients who do not need immunosuppression. The study goal is to find out how common this pattern is in transplant patients, as a first step in determining if it can be used to personalize anti-rejection drug regimens better.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Following surgery, kidney transplant patients must take medications in order to prevent rejection of their transplanted organ. These medications can be very effective. Called immunosuppressive drugs, they work by reducing the activity of the immune system. Because of this, however, they can also have serious side effects, including increased risks of serious infections and certain types of cancer.

The ITN Registry of Tolerant Kidney Transplant Recipients recently identified a rare group of people whose immune system has accepted their transplant without continued use of immunosuppressive drugs. Researchers have found that these patients have a unique pattern of cells and genes expressed in their blood compared to other transplant patients.

The ARTIST study will ask the questions "Are there other transplant patients who show this pattern?" and "If so, how often?"

The goal is to find out if there are other transplant patients who are taking immunosuppression who also show this pattern of genes. If there are others, then this pattern may one day be useful in identifying transplant patients who could reduce the dose of immunosuppression they need without fear of rejection.

Researchers are seeking adults who have received a kidney transplant within the past 1 to 5 years. Participants will be asked to attend 3 short appointments with study doctors over a period of 2 years. At these visits, doctors will request demographic and clinical information, relevant medical histories and blood and urine samples. Participants will be compensated for their time.

It is important to note that this is an observational study only. Other than receiving consultations and advice from the transplant team, there is no direct medical benefit to participating. However, by participating, patients may play an active part in helping doctors learn to control kidney transplant rejection more effectively, with fewer drugs.

Studietype

Observasjonsmessig

Registrering (Faktiske)

250

Kontakter og plasseringer

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

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama Birmingham
    • California
      • San Francisco, California, Forente stater, 94143
        • University of California San Francisco
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forente stater, 02115
        • Beth Israel Deaconess Medical Center
    • New York
      • New York, New York, Forente stater, 10029
        • Mount Sinai School of Medicine
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • The Cleveland Clinic Foundation

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 til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study will include 250 participants who are determined to be eligible for further follow-up based on the eligibility criteria.

Among those eligible for further follow-up

  • at least 25 participants will be renal transplant recipients who received induction therapy with Campath, and
  • at least 25 participants will be renal transplant recipients who are receiving sirolimus or everolimus at time of enrollment and who have not received calcineurin inhibitors for at least 30 days prior to enrollment

Beskrivelse

Inclusion Criteria:

  • Received first kidney transplant from a living or deceased donor.
  • Kidney transplanted between 1 and 5 years ago.
  • Calculated GFR of greater than or equal to 45 mL/min/1.73 m2 within last 6 months
  • Ability to understand and provide informed consent.

Exclusion Criteria:

  • History of steroid-resistant acute rejection
  • History of two or more episodes of acute rejection
  • Any acute rejection in the past year
  • Current malignancy
  • Transplant of another organ
  • AIDS according to the CDC definition of AIDS.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Renal Transplant Recipients
Subjects who received a kidney transplant within the past 1 to 5 years

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The presence of at least one time point of the previously identified renal transplant tolerance signature.
Tidsramme: 2 years
2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.
Tidsramme: 2 years
2 years
Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments
Tidsramme: 2 years
2 years
Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype
Tidsramme: 2 years
2 years
Selected clinical events and laboratory parameters to assess hematologic and renal function
Tidsramme: 2 years
2 years

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Studiestol: Kenneth Newell, MD, PhD, Emory University
  • Studiestol: Laurence Turka, MD, Beth Israel Deaconess Medical Center

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.

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. september 2010

Primær fullføring (Faktiske)

1. april 2014

Studiet fullført (Faktiske)

1. april 2014

Datoer for studieregistrering

Først innsendt

19. januar 2012

Først innsendt som oppfylte QC-kriteriene

19. januar 2012

Først lagt ut (Anslag)

24. januar 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. desember 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. desember 2016

Sist bekreftet

1. desember 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • DAIT ITN524ST/CTOT-12

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Nyretransplantasjon

3
Abonnere