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

9 augusti 2011 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

501

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

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:

  • 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

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: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
Läkemedel: takrolimus
oral
Andra namn:
  • Prograf, FK506
Läkemedel: mykofenolatmofetil
oral
Andra namn:
  • CellCept
  • MMF
Läkemedel: alemtuzumab
Intravenous (IV)
Andra namn:
  • campath
Läkemedel: steroids
IV and/or oral
Aktiv 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
Läkemedel: takrolimus
oral
Andra namn:
  • Prograf, FK506
Läkemedel: mykofenolatmofetil
oral
Andra namn:
  • CellCept
  • MMF
Läkemedel: steroids
IV and/or oral
Läkemedel: rabbit anti-thymocyte globulin
IV
Andra namn:
  • Thymoglobulin
Experimentell: Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
Läkemedel: takrolimus
oral
Andra namn:
  • Prograf, FK506
Läkemedel: mykofenolatmofetil
oral
Andra namn:
  • CellCept
  • MMF
Läkemedel: alemtuzumab
Intravenous (IV)
Andra namn:
  • campath
Läkemedel: steroids
IV and/or oral
Aktiv 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
Läkemedel: takrolimus
oral
Andra namn:
  • Prograf, FK506
Läkemedel: mykofenolatmofetil
oral
Andra namn:
  • CellCept
  • MMF
Läkemedel: steroids
IV and/or oral
Läkemedel: basiliximab
IV
Andra namn:
  • simulect

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Patient Incidence of BCAR
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Astellas Pharma Inc

Utredare

  • Studierektor: Central Contact, Astellas Pharma Global Development

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.

Allmänna publikationer

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

1 maj 2005

Primärt slutförande (Faktisk)

1 mars 2009

Avslutad studie (Faktisk)

1 mars 2009

Studieregistreringsdatum

Först inskickad

7 juni 2005

Först inskickad som uppfyllde QC-kriterierna

7 juni 2005

Första postat (Uppskatta)

8 juni 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

11 augusti 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 augusti 2011

Senast verifierad

1 augusti 2011

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20-04-003

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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