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Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study (CD4-01)

12. oktober 2016 opdateret af: University Hospital, Ghent
This study is an open, randomised trial in which one group of patients (control) will receive the golden standard therapy and the other group (treatment) will receive individually adapted immunosuppression.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

128

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Ghent, Belgien, 9000
        • University Hospital Ghent

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

Beskrivelse

Inclusion Criteria:

  • First or second kidney transplantation
  • Males and females, 18 years old or older
  • Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/mL
  • Patients must be capable of understanding the purpose and risks of the study and must sign an informed consent form

Exclusion Criteria:

  • Multiple organ transplantation (eg. kidney-pancreas, kidney-heart, kidney-liver,...)
  • Transplantation of a patient who received another organ transplant previously except one kidney transplant
  • Recipients of HLA-identical living-related renal transplants
  • Patients with PRA > 10%, patients who have lost a first graft from rejection.
  • Pregnant or lactating women
  • WBC =< 2.5 x 109/L (IU), platelet count =< 100 x 109/L (IU), or Hb =< 6g/dl at the time of entry into the study
  • Active peptic ulcer
  • Severe diarrhea or other gastrointestinal disorders which might interfere with the ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
  • Known HIV-1 or HTLV-1 positive tests
  • History of malignancy in the past 5 years (with the exception of adequately treated basal or squamous skin cell carcinoma)
  • The use of investigational drugs or other immunosuppressive drugs as those specified in this protocol
  • Patients receiving bile acid sequestrants
  • Psychological illness or condition interfering with the patient's compliance or ability to understand the requirements of the study.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
individual adapted immunosuppression
Medicin: individual adapted immunosuppression
individual adapted immunosuppression
Aktiv komparator: 2
golden standard therapy
Medicin: golden standard therapy
golden standard therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Graft function as measured by Cr EDTA AUC
Tidsramme: at 1 year
at 1 year

Sekundære resultatmål

Resultatmål
Tidsramme
Graft survival
Tidsramme: at 1 year
at 1 year
Patient survival
Tidsramme: at 1 year
at 1 year
Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)
Tidsramme: at 1 year
at 1 year
Frequency of biopsy proven acute rejection episodes
Tidsramme: at 1 year
at 1 year
Incidence of biopsy proven acute rejection (BPAR) and clinical (non-biopsy proven) acute rejection episodes treated by a full course anti-rejection therapy (e.g. steroids) (Treatment of rejection according to center practice).
Tidsramme: at 1 year
at 1 year
Incidence of rejection treated by antibodies (OKT3, ATG)
Tidsramme: at 1 year
at 1 year
Time to first rejection (days)
Tidsramme: at 1 year
at 1 year
Severity of rejection as assessed by BANFF 2005 score
Tidsramme: at 1 year
at 1 year
Number of acute rejections per patient
Tidsramme: at 1 year
at 1 year
Plasma creatinine and eGFR
Tidsramme: at month 1, 3 and yearly (2 and 3 years)
at month 1, 3 and yearly (2 and 3 years)
Measured GFR
Tidsramme: at month 3 and yearly
at month 3 and yearly
Proteinuria
Tidsramme: at month 1, 3 and at 1 and 3 years
at month 1, 3 and at 1 and 3 years
Incidence and score of borderline changes and acute rejection
Tidsramme: in month 3 and month 12 biopsy
in month 3 and month 12 biopsy
Incidence and score of chronic alloimmune injury/rejection and nonimmune injury
Tidsramme: in month 3 and month 12 biopsies (BANFF 2005)
in month 3 and month 12 biopsies (BANFF 2005)
Development and evolution of glucose abnormalities
Tidsramme: at 1 year
at 1 year
blood pressure
Tidsramme: at 1 year
at 1 year
ambulatory 24-hr blood pressure monitoring
Tidsramme: at 1 year and 3 years
at 1 year and 3 years
Left ventricular mass assessed by echocardiography
Tidsramme: at 1 year and 3 years
at 1 year and 3 years
Fasting lipid profile
Tidsramme: at baseline, month 1,3,6 and yearly
at baseline, month 1,3,6 and yearly
CMV infection (as measured with whole blood PCR) and disease
Tidsramme: at 1 year
at 1 year
Polyoma virus replication as measured by whole blood PCR
Tidsramme: at 1 year
at 1 year
Incidence of BK nephritis
Tidsramme: in month 3 and month 12 biopsies
in month 3 and month 12 biopsies
Incidence of PTLD and Nonmelanoma skin cancer
Tidsramme: at 1 year and yearly
at 1 year and yearly
Incidence of EBV reactivation (as measured with whole blood PCR)
Tidsramme: at 1 year and yearly
at 1 year and yearly

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital, Ghent

Samarbejdspartnere

Roche Pharma AG

Efterforskere

  • Ledende efterforsker: Raymond Vanholder, MD, PhD, University Hospital, Ghent

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.

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. maj 2009

Primær færdiggørelse (Faktiske)

1. august 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

7. maj 2009

Først indsendt, der opfyldte QC-kriterier

7. maj 2009

Først opslået (Skøn)

8. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2008/640

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 .

Kliniske forsøg med Nyretransplantation

Kliniske forsøg med individual adapted immunosuppression

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner