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Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

25. maj 2011 opdateret af: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized Open-Label Study To Compare The Safety And Efficacy Of Conversion From A Calcineurin Inhibitor To Sirolimus Vs Continued Use Of A Calcineurin Inhibitor In Heart Transplant Recipients With Mild-Moderate Impaired Renal Function

The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

121

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2010
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Pfizer Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
  • Forenede Stater
    • Florida
      • Tampa, Florida, Forenede Stater, 33606
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Pfizer Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10027-6902
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19102
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Pfizer Investigational Site
  • New Zealand
      • Auckland, New Zealand
        • Pfizer Investigational Site
    • Auckland
      • Epsom, Auckland, New Zealand, 1003
        • Pfizer Investigational Site
  • Schweiz
      • Bern, Schweiz, 3010
        • Pfizer Investigational Site
  • Spanien
      • Barcelona, Spanien, 08036
        • Pfizer Investigational Site
      • La Coru?a, Spanien, 15001
        • Pfizer Investigational Site
      • Madrid, Spanien, 28035
        • Pfizer Investigational Site
      • Sevilla, Spanien, 41013
        • Pfizer Investigational Site
      • Valencia, Spanien, 46009
        • Pfizer Investigational Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
        • Pfizer Investigational Site
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Pfizer Investigational Site
  • Østrig
      • Vienna, Østrig, A-1090
        • Pfizer Investigational Site

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:

  • Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
  • 12 months after cardiac transplantation but less than 96 months post-transplantation.

Exclusion Criteria:

  • Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
  • Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
  • History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
Group 1: Continuation of CNI regimen
Medicin: cyclosporine or tacrolimus
Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.
Andre navne:
  • Brand names for cyclosporine are Neoral®, Sandimmune®, and Gengraf®; brand names for tacrolimus are Prograf® and Adagraf™.
Eksperimentel: 2
Group 2: (CNI-Free) Conversion to SRL-based regimen
Medicin: sirolimus
Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.
Andre navne:
  • Rapamune®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization
Tidsramme: Baseline and Week 52
Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (≥) 90 milliliters per minute per 1.73 meters squared (mL/min/1.73m^2). Change from baseline=CC at Week 52 minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.
Baseline and Week 52
Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline
Tidsramme: Baseline
Creatinine clearance at baseline calculated using Cockcroft-Gault equation and adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization
Tidsramme: Baseline and Weeks 4, 16, 24, 32, and 40
Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.
Baseline and Weeks 4, 16, 24, 32, and 40
Change From Baseline in Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at 4, 16, 24, 32, 40 and 52 Weeks Post-randomization
Tidsramme: Baseline and Weeks 4, 16, 24, 32, 40 and 52
Creatinine clearance calculated using MDRD equation. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function. Least squares mean adjusted for baseline calculated creatinine clearance (MDRD) and center.
Baseline and Weeks 4, 16, 24, 32, 40 and 52
Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline
Tidsramme: Baseline
Creatinine clearance calculated using MDRD equation. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.
Baseline
Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization
Tidsramme: Baseline and Weeks 4, 16, 24, 32, 40, and 52
Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week x minus baseline level where higher scores represented decreased kidney function. Least squares mean adjusted for treatment group and center.
Baseline and Weeks 4, 16, 24, 32, 40, and 52
Serum Creatinine Level at Baseline
Tidsramme: Baseline
Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine.
Baseline
Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation)
Tidsramme: Baseline to discontinuation (up to Week 52)
The change in creatinine clearance over time assessed using the random coefficient slope of the regression line with creatinine clearance as the dependent variable and study day as the independent variable. Time points calculated as study days, relative to time of randomization of study medication. Observed data multiplied by a scale factor of 365 to express an annual change.
Baseline to discontinuation (up to Week 52)
Overall Survival (OS)
Tidsramme: Baseline until death (up to Week 56)
Survival time from the start of study treatment to date of death due to any cause, censored at the last visit if no death. Death was determined from the Death report. The distribution of time to death was to be estimated using Kaplan-Meier method and compared between treatment groups with a proportional hazard model. The number and percent of survival at 6 and 12 months were to be reported.
Baseline until death (up to Week 56)
Number of Participants With Acute Rejection
Tidsramme: Baseline to Week 52
Based on International Society for Heart and Lung Transplantation [ISHLT] 1990 criteria: rejections Grade 3A or higher, rejection accompanied by hemodynamic compromise or requiring treatment. Grade 3A or higher included: multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis. Biopsies performed for clinically suspected rejection (for cause), site's standard of care (site protocol biopsy), or protocol mandated.
Baseline to Week 52
Number of Participants With Biopsy-confirmed Acute Rejection by Severity
Tidsramme: Baseline to Week 52
Severity of acute rejection summarized using revised 2005 ISHLT criteria. Grade 0R: no rejection, Grade 1R: Focal (perivascular or interstitial) infiltrate without necrosis, diffuse but sparse infiltrate without necrosis, or one focus only with aggressive infiltration and/or focal myocyte damage, Grade 2R:Multifocal aggressive infiltrates and/or myocyte damage, and Grade 3R:Diffuse inflammatory process with necrosis, or diffuse aggressive polymorphous with necrosis, increased infiltrate, changes in edema, hemorrhage and vasculitis.
Baseline to Week 52
Time to First Acute Rejection
Tidsramme: Baseline to Week 52
Time from baseline to first biopsy-confirmed acute rejection defined as any of the following (based on ISHLT 1990 criteria): all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.
Baseline to Week 52
Number of Participants Requiring Antibody Use in Treatment of Acute Rejection
Tidsramme: Baseline to Week 52
Number of participants requiring antilymphocyte antibody therapy with suspected or biopsy-proven, steroid-resistant, acute rejection with or without hemodynamic compromise. Acute rejection based on ISHLT 1990 criteria: all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.
Baseline to Week 52
Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy
Tidsramme: Baseline up to Week 52
Baseline up to Week 52

Samarbejdspartnere og efterforskere

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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

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. september 2006

Primær færdiggørelse (Faktiske)

1. april 2010

Studieafslutning (Faktiske)

1. maj 2010

Datoer for studieregistrering

Først indsendt

25. august 2006

Først indsendt, der opfyldte QC-kriterier

25. august 2006

Først opslået (Skøn)

29. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. maj 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2011

Sidst verificeret

1. maj 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0468E7-408
  • B1741006 (Anden identifikator: Pfizer)

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 Afvisning af transplantat

Kliniske forsøg med cyclosporine or tacrolimus

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sweden

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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