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Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients (INTAC)

9 agosto 2011 aggiornato da: Astellas Pharma Inc

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

The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

501

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
    • California
      • Los Angeles, California, Stati Uniti, 90057
      • Palo Alto, California, Stati Uniti, 94304
      • San Diego, California, Stati Uniti, 92123
      • San Francisco, California, Stati Uniti, 94115
      • San Francisco, California, Stati Uniti, 94143
    • Colorado
      • Denver, Colorado, Stati Uniti, 80262
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20010
      • Washington, District of Columbia, Stati Uniti, 20007
    • Florida
      • Miami, Florida, Stati Uniti, 33136
      • Tampa, Florida, Stati Uniti, 33066
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
      • Chicago, Illinois, Stati Uniti, 60612
    • New Jersey
      • Livingston, New Jersey, Stati Uniti, 07039
      • New Brunswick, New Jersey, Stati Uniti, 08901
    • New York
      • Hawthorne, New York, Stati Uniti, 10532
      • New York, New York, Stati Uniti, 10032
      • New York, New York, Stati Uniti, 10029
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
      • Durham, North Carolina, Stati Uniti, 27710
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45267
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
    • Pennsylvania
      • Danville, Pennsylvania, Stati Uniti, 17822
      • Harrisburg, Pennsylvania, Stati Uniti, 17105
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
    • Texas
      • San Antonio, Texas, Stati Uniti, 78229
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84132
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53792
      • Milwaukee, Wisconsin, Stati Uniti, 53226

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
Droga: tacrolimo
orale
Altri nomi:
  • Prograf, FK506
Droga: micofenolato mofetile
orale
Altri nomi:
  • CellCept
  • MMF
Droga: alemtuzumab
Intravenous (IV)
Altri nomi:
  • campath
Droga: steroids
IV and/or oral
Comparatore attivo: 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
Droga: tacrolimo
orale
Altri nomi:
  • Prograf, FK506
Droga: micofenolato mofetile
orale
Altri nomi:
  • CellCept
  • MMF
Droga: steroids
IV and/or oral
Droga: rabbit anti-thymocyte globulin
IV
Altri nomi:
  • Timoglobulina
Sperimentale: Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
Droga: tacrolimo
orale
Altri nomi:
  • Prograf, FK506
Droga: micofenolato mofetile
orale
Altri nomi:
  • CellCept
  • MMF
Droga: alemtuzumab
Intravenous (IV)
Altri nomi:
  • campath
Droga: steroids
IV and/or oral
Comparatore attivo: Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
Droga: tacrolimo
orale
Altri nomi:
  • Prograf, FK506
Droga: micofenolato mofetile
orale
Altri nomi:
  • CellCept
  • MMF
Droga: steroids
IV and/or oral
Droga: basiliximab
IV
Altri nomi:
  • simulect

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
Lasso di tempo: 6 months

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Patient Incidence of BCAR
Lasso di tempo: End of Study (36 months)

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)
Efficacy Failure
Lasso di tempo: End of Study (36 months)

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)
Clinically Treated Acute Rejection
Lasso di tempo: End of Study (36 months)

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)
Time to First BCAR
Lasso di tempo: End of Study (36 months)

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)
Graft Survival at 12 Months
Lasso di tempo: 12 months

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
Overall Graft Survival
Lasso di tempo: End of Study (36 months)

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)
Patient Survival at 12 Months
Lasso di tempo: 12 months

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
Overall Patient Survival
Lasso di tempo: End of Study (36 months)

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)
Renal Function Abnormalities Based on Creatinine Clearance
Lasso di tempo: 1 month and End of Study (36 months)

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)
Renal Function Abnormalities Based on Serum Creatinine
Lasso di tempo: 1 month and End of Study (36 months)

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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Astellas Pharma Inc

Investigatori

  • Direttore dello studio: Central Contact, Astellas Pharma Global Development

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2005

Completamento primario (Effettivo)

1 marzo 2009

Completamento dello studio (Effettivo)

1 marzo 2009

Date di iscrizione allo studio

Primo inviato

7 giugno 2005

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2005

Primo Inserito (Stima)

8 giugno 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 agosto 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 agosto 2011

Ultimo verificato

1 agosto 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20-04-003

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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