- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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
Studietype
Intervensjonell
Registrering (Faktiske)
281
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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 navn:
Low dose, Oral
Andre navn:
IV
Andre navn:
Oral
Andre navn:
IV and Oral
Andre navn:
Oral
Andre navn:
Oral
Andre navn:
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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 navn:
Low dose, Oral
Andre navn:
IV
Andre navn:
Oral
Andre navn:
IV and Oral
Andre navn:
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Eksperimentell: Tacrolimus Low Dose with ACEi/ARB
Participants receive a low dose of tacrolimus with ACEi/ARB.
|
Standard dose, Oral
Andre navn:
Low dose, Oral
Andre navn:
IV
Andre navn:
Oral
Andre navn:
IV and Oral
Andre navn:
Oral
Andre navn:
Oral
Andre navn:
|
Eksperimentell: Tacrolimus Low Dose without ACEi/ARB
Participants receive a low dose of tacrolimus without ACEi/ARB.
|
Standard dose, Oral
Andre navn:
Low dose, Oral
Andre navn:
IV
Andre navn:
Oral
Andre navn:
IV and Oral
Andre navn:
|
Hva måler studien?
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 |
Tiltaksbeskrivelse |
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
|
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
|
Percentage of Participants with Polyomavirus Infection
Tidsramme: up to 12 months
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up to 12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Principal Investigator, University of Alberta
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
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 (Faktiske)
17. august 2009
Primær fullføring (Faktiske)
11. mai 2015
Studiet fullført (Faktiske)
3. april 2018
Datoer for studieregistrering
Først innsendt
2. juli 2009
Først innsendt som oppfylte QC-kriteriene
6. juli 2009
Først lagt ut (Anslag)
7. juli 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Anti-infeksjonsmidler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Proteasehemmere
- Nevrobeskyttende midler
- Beskyttende agenter
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Angiotensin II type 1-reseptorblokkere
- Angiotensinreseptorantagonister
- Antituberkulære midler
- Angiotensin-konverterende enzymhemmere
- Antibiotika, Antituberkulær
- Calcineurin-hemmere
- Metylprednisolon
- Prednison
- Takrolimus
- Mykofenolsyre
- Basiliximab
- Ramipril
- Irbesartan
Andre studie-ID-numre
- FKC-014
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .
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