- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00113269
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients (INTAC)
Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
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California
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Los Angeles, California, Vereinigte Staaten, 90057
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Palo Alto, California, Vereinigte Staaten, 94304
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San Diego, California, Vereinigte Staaten, 92123
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San Francisco, California, Vereinigte Staaten, 94115
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San Francisco, California, Vereinigte Staaten, 94143
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80262
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20010
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Washington, District of Columbia, Vereinigte Staaten, 20007
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Florida
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Miami, Florida, Vereinigte Staaten, 33136
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Tampa, Florida, Vereinigte Staaten, 33066
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
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Chicago, Illinois, Vereinigte Staaten, 60612
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New Jersey
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Livingston, New Jersey, Vereinigte Staaten, 07039
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New Brunswick, New Jersey, Vereinigte Staaten, 08901
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New York
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Hawthorne, New York, Vereinigte Staaten, 10532
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New York, New York, Vereinigte Staaten, 10032
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New York, New York, Vereinigte Staaten, 10029
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599
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Durham, North Carolina, Vereinigte Staaten, 27710
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45267
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97239
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Pennsylvania
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Danville, Pennsylvania, Vereinigte Staaten, 17822
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Harrisburg, Pennsylvania, Vereinigte Staaten, 17105
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29425
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Texas
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San Antonio, Texas, Vereinigte Staaten, 78229
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84132
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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53792
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).
Exclusion Criteria:
- Patient has previously received an organ transplant other than a kidney
- Patient receiving chronic steroid therapy at time of transplant
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
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Oral
Andere Namen:
Oral
Andere Namen:
Intravenous (IV)
Andere Namen:
IV and/or oral
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Aktiver Komparator: Conventional High-Risk Patients
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
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Oral
Andere Namen:
Oral
Andere Namen:
IV and/or oral
IV
Andere Namen:
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Experimental: Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
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Oral
Andere Namen:
Oral
Andere Namen:
Intravenous (IV)
Andere Namen:
IV and/or oral
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Aktiver Komparator: Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
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Oral
Andere Namen:
Oral
Andere Namen:
IV and/or oral
IV
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
Zeitfenster: 6 months
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A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st. |
6 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall Patient Incidence of BCAR
Zeitfenster: End of Study (36 months)
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Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3). End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Efficacy Failure
Zeitfenster: End of Study (36 months)
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Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Clinically Treated Acute Rejection
Zeitfenster: End of Study (36 months)
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Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Time to First BCAR
Zeitfenster: End of Study (36 months)
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Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Graft Survival at 12 Months
Zeitfenster: 12 months
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Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first. |
12 months
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Overall Graft Survival
Zeitfenster: End of Study (36 months)
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Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Patient Survival at 12 Months
Zeitfenster: 12 months
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Patient survival is defined as not dead within 12 months after skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first. |
12 months
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Overall Patient Survival
Zeitfenster: End of Study (36 months)
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Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Renal Function Abnormalities Based on Creatinine Clearance
Zeitfenster: 1 month and End of Study (36 months)
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Increases in creatinine clearance usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1. |
1 month and End of Study (36 months)
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Renal Function Abnormalities Based on Serum Creatinine
Zeitfenster: 1 month and End of Study (36 months)
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Decrease in serum creatinine usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1. |
1 month and End of Study (36 months)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Central Contact, Astellas Pharma Global Development
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Antineoplastische Mittel, immunologische
- Antibakterielle Mittel
- Antibiotika, antineoplastische
- Antituberkulöse Mittel
- Antibiotika, Antituberkulose
- Calcineurin-Inhibitoren
- Tacrolimus
- Mycophenolsäure
- Basiliximab
- Thymoglobulin
- Antilymphozyten-Serum
- Alemtuzumab
Andere Studien-ID-Nummern
- 20-04-003
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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