- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00933231
Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts
3. april 2019 opdateret af: Astellas Pharma Inc
A Comparison of Effects of Standard Dose vs. Low Dose Advagraf® With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response
This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The study will consist of the following 4 treatment groups.:
- Standard dose Advagraf with angiotensin-converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) antihypertensive therapy
- Standard dose Advagraf without ACEi/ARB antihypertensive therapy
- Low dose Advagraf with ACEi/ARB antihypertensive therapy
- Low dose Advagraf without ACEi/ARB antihypertensive therapy
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
281
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Quebec, Canada, G1R 2J6
- Site CA64 Centre Hospitalier Universitaire de Québec- L'Hôtel-dieu de Québec
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Site CA133 Foothills Medical Centre
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Edmonton, Alberta, Canada, T6G 2B7
- Site CA54 University of Alberta Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Site CA141 Health Sciences Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Site CA114 Capital District Health Authority- QEII Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- Site CA150 St. Joseph's Healthcare
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London, Ontario, Canada, N6A 5A5
- Site CA27 London Health Sciences Centre
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Toronto, Ontario, Canada, M5C 2T2
- Site CA165 St. Michael's Hospital
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Site CA238 Hôpital Maisonneuve-Rosemont
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Montreal, Quebec, Canada, H2L 4M1
- Site CA172 Hôpital Notre-Dame du CHUM
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Montreal, Quebec, Canada, H4A 3J1
- Site CA144 McGill University Health Centre
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Sherbrooke, Quebec, Canada, J1H 5N4
- Site CA116 Centre Hospitalier Universitaire de Sherbrooke- Hôpital Fleuirmont
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7V 0Z9
- Site CA142 St. Paul's Hospital
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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:
- Subject is the recipient of a first or second deceased or living donor renal transplant (one kidney only)
- Subject must have at least one HLA-mismatch with the donor. HLA identical donor-recipient pairs are not eligible
- Subject understands either English or French
- If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
Exclusion Criteria:
- Presence of donor specific antibody
- Subject who is currently participating in a study with investigational drug, or who has received investigational drug within three months prior to randomization. Observational studies are acceptable
- Subject who has lost a previous graft for immunological reasons less than one year from transplant
- Subject is pregnant or breastfeeding
- Subject receives a kidney lacking pre-implantation biopsy
- Subject has significant disease (e.g. malignancy or uncontrolled infection) or disability (e.g. cognitive defect) which prevents understanding of, or adherence to the protocol
- Subject who in the opinion of the Investigator, require ACEi/ARB therapy post-transplant for any indication
- Subject who requires induction with Thymoglobulin, Campath, antithymocyte globulin (ATG), antilymphocyte globulin (ALG) or any biological induction agent other than basiliximab. Unplanned post-transplant use of these prohibited drugs for clinical indications post-transplant is allowed
- Subject has plans to become pregnant within 2 years post-transplant
- Subject who has a positive T-cell or B-cell crossmatch. Subjects with a weakly positive B-cell cross-match that tests negative following DTT reduction are acceptable
- Subject who has a requirement for maintenance immunosuppressant therapy with the exception of low dose steroid or mycophenolate mofetil (MMF). A subject who is on low dose tacrolimus maintenance therapy will be eligible provided the tacrolimus is withheld at least 1 week prior to transplant
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: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Tacrolimus Standard Dose with ACEi/ARB
Participants receive a standard dose of tacrolimus with ACEi/ARB.
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Standard dose, Oral
Andre navne:
Low dose, Oral
Andre navne:
IV
Andre navne:
Oral
Andre navne:
IV and Oral
Andre navne:
Oral
Andre navne:
Oral
Andre navne:
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Aktiv komparator: Tacrolimus Standard Dose without ACEi/ARB
Participants receive a standard dose of tacrolimus without ACEi/ARB.
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Standard dose, Oral
Andre navne:
Low dose, Oral
Andre navne:
IV
Andre navne:
Oral
Andre navne:
IV and Oral
Andre navne:
|
Eksperimentel: Tacrolimus Low Dose with ACEi/ARB
Participants receive a low dose of tacrolimus with ACEi/ARB.
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Standard dose, Oral
Andre navne:
Low dose, Oral
Andre navne:
IV
Andre navne:
Oral
Andre navne:
IV and Oral
Andre navne:
Oral
Andre navne:
Oral
Andre navne:
|
Eksperimentel: Tacrolimus Low Dose without ACEi/ARB
Participants receive a low dose of tacrolimus without ACEi/ARB.
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Standard dose, Oral
Andre navne:
Low dose, Oral
Andre navne:
IV
Andre navne:
Oral
Andre navne:
IV and Oral
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of Participants with the Presence of Allograft Interstitial Fibrosis and Tubular Atrophy (IF/TA) as Assessed at a Central Pathology Lab
Tidsramme: up to 24 months
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up to 24 months
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Progression of IF/TA from Month 6 to Month 24
Tidsramme: up to 24 months
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up to 24 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time to T-cell Banff Mediated Rejection as Assessed at a Central Pathology Lab
Tidsramme: up to 24 months
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up to 24 months
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Percentage of Participants in Each Category of Banff 2007 Diagnostic Classification of Renal Allograft Pathology
Tidsramme: up to 24 months
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up to 24 months
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Percentage of Participants with Humoral Rejections
Tidsramme: up to 24 months
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up to 24 months
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Percentage of Participants with Acute Rejections
Tidsramme: up to 24 months
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up to 24 months
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Time to First Any Acute Rejection
Tidsramme: up to 24 months
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up to 24 months
|
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Banff 2007 Individual Sub-scores
Tidsramme: up to 24 months
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Banff 2007 sub-scores (AH = Arteriolar hyalinethickening score; AT = Tubulitis score; AV = Intimal arteritis score; AI = Interstitial inflammation score; AG = Glomerulitis score; CG = Glomerulopathy score; CI = Interstitial fibrosis score; CT = Tubularatrophy score; CV = Vascular fibrous intimal thickening score; MM = Mesangial matrix increase score; TI = Total interstitial inflammation score; PTC = Peritubulary capillaritis score) is measured on an ordinal scale of 0 - 3.
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up to 24 months
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Change from Baseline in Chronic Allograft Damage Index
Tidsramme: Baseline and 6, 24 months
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Baseline and 6, 24 months
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Percentage of Participants with Circulating Anti-Donor Antibody
Tidsramme: up to 5 years
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up to 5 years
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Number of Participants with Cellular Immune Response (ELISPOT)
Tidsramme: up to 6 months
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up to 6 months
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Urine Renal Biomarkers
Tidsramme: up to 24 months
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up to 24 months
|
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Graft Survival
Tidsramme: up to 5 years
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up to 5 years
|
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Patient Survival
Tidsramme: up to 5 years
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up to 5 years
|
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Renal Function as Measured by Glomerular Filtration Rate (GFR)
Tidsramme: up to 5 years
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up to 5 years
|
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Renal Function as Measured by Serum Creatinine
Tidsramme: up to 5 years
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up to 5 years
|
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Renal Function as Measured by Ratio of Urine Protein and Creatinine Concentrations
Tidsramme: up to 5 years
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up to 5 years
|
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12-Item Short Form (SF-12) Health Survey: Physical Composite Score (PCS) and Mental Health Composite Score (MCS)
Tidsramme: up to 24 months
|
The PCS and MCS are measured on a normalized 0-100 scale and computed using the corresponding subdomains from the SF-12 with 0 being the lowest level of health and 100 the highest.
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up to 24 months
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Kidney Transplant Recipient Opinions of Immunosuppressive Medications Questionnaire
Tidsramme: up to 24 months
|
This questionnaire consists of 11 questions regarding immunosuppressive medications, where questions 1-3 ask about your experiences and opinions of transplant anti-rejection medications, questions 4 and 11 ask to rate each medication on the scale of 1-10, with 1 meaning disagree completely and 10 meaning agree completely, and questions 5-10 ask which medication satisfies the question.
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up to 24 months
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Percentage of Participants with Polyomavirus Infection
Tidsramme: up to 12 months
|
up to 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Principal Investigator, University of Alberta
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 (Faktiske)
17. august 2009
Primær færdiggørelse (Faktiske)
11. maj 2015
Studieafslutning (Faktiske)
3. april 2018
Datoer for studieregistrering
Først indsendt
2. juli 2009
Først indsendt, der opfyldte QC-kriterier
6. juli 2009
Først opslået (Skøn)
7. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Anti-infektionsmidler
- Autonome agenter
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Proteasehæmmere
- Neuroprotektive midler
- Beskyttelsesagenter
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Angiotensin II Type 1-receptorblokkere
- Angiotensinreceptorantagonister
- Antituberkulære midler
- Angiotensin-konverterende enzymhæmmere
- Antibiotika, Antituberkulær
- Calcineurin-hæmmere
- Methylprednisolon
- Prednison
- Tacrolimus
- Mycophenolsyre
- Basiliximab
- Ramipril
- Irbesartan
Andre undersøgelses-id-numre
- FKC-014
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development.
Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD-delingstidsramme
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD-delingsadgangskriterier
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
The research proposal is reviewed by an Independent Research Panel.
If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .
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