- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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
Studietyp
Interventionell
Inskrivning (Faktisk)
281
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Quebec, Kanada, 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, Kanada, T2N 2T9
- Site CA133 Foothills Medical Centre
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Edmonton, Alberta, Kanada, T6G 2B7
- Site CA54 University of Alberta Hospital
-
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Manitoba
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Winnipeg, Manitoba, Kanada, R3A 1R9
- Site CA141 Health Sciences Centre
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-
Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 1V7
- Site CA114 Capital District Health Authority- QEII Health Sciences Centre
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Ontario
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Hamilton, Ontario, Kanada, L8N 4A6
- Site CA150 St. Joseph's Healthcare
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London, Ontario, Kanada, N6A 5A5
- Site CA27 London Health Sciences Centre
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Toronto, Ontario, Kanada, M5C 2T2
- Site CA165 St. Michael's Hospital
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
- Site CA238 Hôpital Maisonneuve-Rosemont
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Montreal, Quebec, Kanada, H2L 4M1
- Site CA172 Hôpital Notre-Dame du CHUM
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Montreal, Quebec, Kanada, H4A 3J1
- Site CA144 McGill University Health Centre
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Sherbrooke, Quebec, Kanada, J1H 5N4
- Site CA116 Centre Hospitalier Universitaire de Sherbrooke- Hôpital Fleuirmont
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7V 0Z9
- Site CA142 St. Paul's Hospital
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Tacrolimus Standard Dose with ACEi/ARB
Participants receive a standard dose of tacrolimus with ACEi/ARB.
|
Standard dose, Oral
Andra namn:
Low dose, Oral
Andra namn:
IV
Andra namn:
Oral
Andra namn:
IV and Oral
Andra namn:
Oral
Andra namn:
Oral
Andra namn:
|
Aktiv komparator: Tacrolimus Standard Dose without ACEi/ARB
Participants receive a standard dose of tacrolimus without ACEi/ARB.
|
Standard dose, Oral
Andra namn:
Low dose, Oral
Andra namn:
IV
Andra namn:
Oral
Andra namn:
IV and Oral
Andra namn:
|
Experimentell: Tacrolimus Low Dose with ACEi/ARB
Participants receive a low dose of tacrolimus with ACEi/ARB.
|
Standard dose, Oral
Andra namn:
Low dose, Oral
Andra namn:
IV
Andra namn:
Oral
Andra namn:
IV and Oral
Andra namn:
Oral
Andra namn:
Oral
Andra namn:
|
Experimentell: Tacrolimus Low Dose without ACEi/ARB
Participants receive a low dose of tacrolimus without ACEi/ARB.
|
Standard dose, Oral
Andra namn:
Low dose, Oral
Andra namn:
IV
Andra namn:
Oral
Andra namn:
IV and Oral
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Percentage of Participants with the Presence of Allograft Interstitial Fibrosis and Tubular Atrophy (IF/TA) as Assessed at a Central Pathology Lab
Tidsram: up to 24 months
|
up to 24 months
|
Progression of IF/TA from Month 6 to Month 24
Tidsram: up to 24 months
|
up to 24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to T-cell Banff Mediated Rejection as Assessed at a Central Pathology Lab
Tidsram: up to 24 months
|
up to 24 months
|
|
Percentage of Participants in Each Category of Banff 2007 Diagnostic Classification of Renal Allograft Pathology
Tidsram: up to 24 months
|
up to 24 months
|
|
Percentage of Participants with Humoral Rejections
Tidsram: up to 24 months
|
up to 24 months
|
|
Percentage of Participants with Acute Rejections
Tidsram: up to 24 months
|
up to 24 months
|
|
Time to First Any Acute Rejection
Tidsram: up to 24 months
|
up to 24 months
|
|
Banff 2007 Individual Sub-scores
Tidsram: up to 24 months
|
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.
|
up to 24 months
|
Change from Baseline in Chronic Allograft Damage Index
Tidsram: Baseline and 6, 24 months
|
Baseline and 6, 24 months
|
|
Percentage of Participants with Circulating Anti-Donor Antibody
Tidsram: up to 5 years
|
up to 5 years
|
|
Number of Participants with Cellular Immune Response (ELISPOT)
Tidsram: up to 6 months
|
up to 6 months
|
|
Urine Renal Biomarkers
Tidsram: up to 24 months
|
up to 24 months
|
|
Graft Survival
Tidsram: up to 5 years
|
up to 5 years
|
|
Patient Survival
Tidsram: up to 5 years
|
up to 5 years
|
|
Renal Function as Measured by Glomerular Filtration Rate (GFR)
Tidsram: up to 5 years
|
up to 5 years
|
|
Renal Function as Measured by Serum Creatinine
Tidsram: up to 5 years
|
up to 5 years
|
|
Renal Function as Measured by Ratio of Urine Protein and Creatinine Concentrations
Tidsram: up to 5 years
|
up to 5 years
|
|
12-Item Short Form (SF-12) Health Survey: Physical Composite Score (PCS) and Mental Health Composite Score (MCS)
Tidsram: 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.
|
up to 24 months
|
Kidney Transplant Recipient Opinions of Immunosuppressive Medications Questionnaire
Tidsram: 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.
|
up to 24 months
|
Percentage of Participants with Polyomavirus Infection
Tidsram: up to 12 months
|
up to 12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Principal Investigator, University of Alberta
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
17 augusti 2009
Primärt slutförande (Faktisk)
11 maj 2015
Avslutad studie (Faktisk)
3 april 2018
Studieregistreringsdatum
Först inskickad
2 juli 2009
Först inskickad som uppfyllde QC-kriterierna
6 juli 2009
Första postat (Uppskatta)
7 juli 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 april 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 april 2019
Senast verifierad
1 april 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antihypertensiva medel
- Anti-infektionsmedel
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Enzyminhibitorer
- Antiinflammatoriska medel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Proteashämmare
- Neuroprotektiva medel
- Skyddsmedel
- Antibakteriella medel
- Antibiotika, antineoplastiska
- Angiotensin II typ 1-receptorblockerare
- Angiotensinreceptorantagonister
- Antituberkulära medel
- Angiotensin-konverterande enzymhämmare
- Antibiotika, Antituberkulära
- Calcineurin-hämmare
- Metylprednisolon
- Prednison
- Takrolimus
- Mykofenolsyra
- Basiliximab
- Ramipril
- Irbesartan
Andra studie-ID-nummer
- FKC-014
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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