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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 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

Fase

Fase 3

Kontakter og plasseringer

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

Studiesteder

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

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

35 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Aktiv komparator: 1 Tacrolimus + MMF + Steroids	Legemiddel: 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. Andre navn: CNI Legemiddel: 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. Andre navn: MMF, MPS Legemiddel: 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. Andre navn: CCS Legemiddel: 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. Andre navn: CNI
Eksperimentell: 2 Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant	Legemiddel: 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. Andre navn: CNI Legemiddel: 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. Andre navn: MMF, MPS Legemiddel: 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. Andre navn: CCS Legemiddel: 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. Andre navn: CNI Legemiddel: 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.

Deltakergruppe / Arm

Intervensjon / Behandling

Aktiv komparator: 1

Tacrolimus + MMF + Steroids

Legemiddel: 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.

Andre navn:

Legemiddel: 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.

Andre navn:

MMF, MPS

Legemiddel: 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.

Andre navn:

Legemiddel: 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.

Andre navn:

Eksperimentell: 2

Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant

Legemiddel: tacrolimus

Andre navn:

Legemiddel: 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.

Andre navn:

MMF, MPS

Legemiddel: 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.

Andre navn:

Legemiddel: 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.

Andre navn:

Legemiddel: sirolimus

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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant Tidsramme: 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 Tidsramme: Pre-conversion baseline	TPV is the sum of the assessment in left and right distal common carotid arteries.	Pre-conversion baseline

Sekundære resultatmål

Samarbeidspartnere og etterforskere

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

Sponsor

Pfizer

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.

Hjelpsomme linker

To obtain contact information for a study center near you, click here.

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. april 2006

Primær fullføring (Faktiske)

1. desember 2010

Studiet fullført (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først innsendt

3. april 2006

Først innsendt som oppfylte QC-kriteriene

3. april 2006

Først lagt ut (Anslag)

5. april 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. september 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juli 2013

Sist bekreftet

1. juli 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

0468H1-319

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 tacrolimus

Hospital Universitari de Bellvitge

Fullført

Konverteringsfarmakodynamisk studie hos stabile nyretransplanterte pasienter som får takrolimus to ganger daglig til en ny formulering av takrolimus - LCP Tacro - 1 gang om dagen. (TACPKPD)

Nyretransplantasjon; Komplikasjoner

Spania
Loyola University
Veloxis Pharmaceuticals

Rekruttering

Nyretubulær skade og transplantasjonsutfall hos hjertemottakere som konverterer fra IR takrolimus til XR takrolimus

Kroniske nyresykdommer | Hjertetransplantasjon

Forente stater
Astellas Pharma Inc

Fullført

Takrolimus og Daclizumab versus takrolimus og steroider hos levermottakere som får sub-optimale transplantater (PANTERA)

LEVERTRANSPLANTASJON

Italia
Georgetown University

Avsluttet

Envarsus XR hos afroamerikanske nyretransplantasjonsmottakere (EXR)

Nyretransplantasjonsmottakere

Forente stater
Yonsei University

Fullført

Studie for å evaluere sikkerheten og effekten av takrolimus med forlenget frigivelse (Advagraf®) + Sirolimus (Rapamune®), versus takrolimus med forlenget frigivelse (Advagraf®) + mykofenolatmofetil hos nyretransplanterte pasienter

Nyretransplanterte pasienter

Korea, Republikken
Nantes University Hospital

Har ikke rekruttert ennå

Fase 3-studie av takrolimusminimering hos nyretransplantasjonsmottakere valgt i henhold til AGORA-algoritmen for deres lave immunologiske risiko og middels langvarig transplantasjonssvikt (AGORAC)

Organtransplantasjoner

Norge, Spania, Frankrike
Hospices Civils de Lyon

Fullført

Effekt og sikkerhet av en 0,1 % takrolimus nesesalve som en behandling for neseblødning ved hemorragisk arvelig telangiektasi (HHT) (TACRO)

Hemorragisk arvelig telangiectasia (HHT)

Frankrike
University of Utah
National Heart, Lung, and Blood Institute (NHLBI)

Aktiv, ikke rekrutterende

Presisjonsveiledet takrolimusdosering ved pediatrisk hjertetransplantasjon

Hjertetransplantasjonssvikt og avvisning

Forente stater
Taro Pharmaceuticals USA

Fullført

Bioekvivalens av to takrolimus 0,1 % topiske salveformuleringer hos pasienter med atopisk dermatitt

Atopisk dermatitt
Ain Shams University
National Hepatology & Tropical Medicine Research Institute

Fullført

Takrolimus versus hydrokortison ved atopisk dermatitt

Dermatitt | Atopisk

Egypt

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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. Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

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

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

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Faktiske)

Fase

Kontakter og plasseringer

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Publikasjoner og nyttige lenker

Hjelpsomme linker

Studierekorddatoer

Studer hoveddatoer

Studiestart

Primær fullføring (Faktiske)

Studiet fullført (Faktiske)

Datoer for studieregistrering

Først innsendt

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