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Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients

19. Juli 2013 aktualisiert von: Pfizer

A Prospective, Randomized, Open-Label, Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Recipients

The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

A decision to terminate the study was taken in November 2011 and a communication to that effect sent to all participating sites on November 18. All sites were asked to have patients returned to the sites and have all end of study procedures performed by Dec 31, 2011.

The decision to terminate this study was made following the conduct of an interim analysis which demonstrated that the study did not reach its primary endpoint. The termination of this study was not driven by any safety concerns and had no impact on subject safety and well-being.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

72

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 2T9
        • Pfizer Investigational Site
      • Edmonton, Alberta, Kanada, T6G 2B7
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Kanada, L8N 4A6
        • Pfizer Investigational Site
      • London, Ontario, Kanada, N6A 5A5
        • Pfizer Investigational Site
      • Toronto, Ontario, Kanada, M5C 2T2
        • Pfizer Investigational Site
      • Toronto, Ontario, Kanada, M5B 1W8
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Kanada, H1T 2M4
        • Pfizer Investigational Site
  • Vereinigte Staaten
    • New York
      • Rochester, New York, Vereinigte Staaten, 14642
        • Pfizer Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

35 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

At least one of the following characteristics:

  • History of dialysis for at least 3 years.
  • History of diabetes for at least 5 years.
  • Hypertension or ischemic nephropathy as a cause of the end stage renal disease or loss of the first transplant.
  • History of coronary artery disease, stroke, myocardial infarction, or amputation for vascular disease.

Exclusion Criteria:

  • History of malignancy within the last 5 years (except adequately treated skin cancer).
  • Recipients of non-renal organ transplant.
  • Active gastrointestinal disease that may interfere with drug absorption.
  • Active HIV, hepatitis B or C infection.
  • Women who are pregnant or breastfeeding.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 1
Tacrolimus + MMF + Steroids
Arzneimittel: tacrolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.
Andere Namen:
  • CNI
Arzneimittel: mycophenolate mofetil
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
Andere Namen:
  • MMF, MPS
Arzneimittel: prednisone
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
Andere Namen:
  • CCS
Arzneimittel: tacrolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. Reintroduction of TAC or introduction of CsA is not permitted in the SRL Therapy group.
Andere Namen:
  • CNI
Experimental: 2
Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant
Arzneimittel: tacrolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.
Andere Namen:
  • CNI
Arzneimittel: mycophenolate mofetil
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
Andere Namen:
  • MMF, MPS
Arzneimittel: prednisone
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
Andere Namen:
  • CCS
Arzneimittel: tacrolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. Reintroduction of TAC or introduction of CsA is not permitted in the SRL Therapy group.
Andere Namen:
  • CNI
Arzneimittel: sirolimus

The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol.

On study Day 1 Conversion, the daily dose of TAC will not be taken, and SRL is initiated as a single 5-10 mg loading dose, followed by 3 mg/day on subsequent days, adjusted to maintain a SRL target trough level of 8-15 ng/mL through to month 24 post-transplant, then 5-12 ng/mL to the end of month 36 post-transplant.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant
Zeitfenster: Pre-conversion baseline and 12 months post-transplant
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
Pre-conversion baseline and 12 months post-transplant
TPV at Pre-conversion Baseline
Zeitfenster: Pre-conversion baseline
TPV is the sum of the assessment in left and right distal common carotid arteries.
Pre-conversion baseline

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant
Zeitfenster: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years.
Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
CIMT at Pre-conversion Baseline
Zeitfenster: Pre-conversion baseline
Mean CIMT=average of left CIMT and right CIMT.
Pre-conversion baseline
Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant
Zeitfenster: Pre-conversion baseline, 12, and 24 months post-transplant
Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.
Pre-conversion baseline, 12, and 24 months post-transplant
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant
Zeitfenster: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline.
Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
HbA1C, change = value at month x post-transplant - pre-conversion baseline.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant
Zeitfenster: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Number of Participants Who Used Lipid Lowering Therapies
Zeitfenster: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Participants who reported "yes" for taking lipid lowering therapies as concomitant medication.
From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Number of Participants Who Used Anti-hypertensive Medications
Zeitfenster: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Participants who reported "yes" for taking anti-hypertensive medications as concomitant medication.
From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant
Zeitfenster: Pre-conversion baseline, and 18, 24 and 36 months post-transplant
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
Pre-conversion baseline, and 18, 24 and 36 months post-transplant

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2006

Primärer Abschluss (Tatsächlich)

1. Dezember 2010

Studienabschluss (Tatsächlich)

1. Januar 2012

Studienanmeldedaten

Zuerst eingereicht

3. April 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. April 2006

Zuerst gepostet (Schätzen)

5. April 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

23. September 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Juli 2013

Zuletzt verifiziert

1. Juli 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 0468H1-319

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