- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294
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California
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Los Angeles, California, États-Unis, 90057
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Palo Alto, California, États-Unis, 94304
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San Diego, California, États-Unis, 92123
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San Francisco, California, États-Unis, 94115
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San Francisco, California, États-Unis, 94143
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Colorado
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Denver, Colorado, États-Unis, 80262
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District of Columbia
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Washington, District of Columbia, États-Unis, 20010
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Washington, District of Columbia, États-Unis, 20007
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Florida
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Miami, Florida, États-Unis, 33136
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Tampa, Florida, États-Unis, 33066
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Illinois
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Chicago, Illinois, États-Unis, 60611
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Chicago, Illinois, États-Unis, 60612
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New Jersey
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Livingston, New Jersey, États-Unis, 07039
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New Brunswick, New Jersey, États-Unis, 08901
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New York
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Hawthorne, New York, États-Unis, 10532
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New York, New York, États-Unis, 10032
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New York, New York, États-Unis, 10029
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
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Durham, North Carolina, États-Unis, 27710
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Ohio
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Cincinnati, Ohio, États-Unis, 45267
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Oregon
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Portland, Oregon, États-Unis, 97239
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Pennsylvania
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Danville, Pennsylvania, États-Unis, 17822
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Harrisburg, Pennsylvania, États-Unis, 17105
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
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Texas
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San Antonio, Texas, États-Unis, 78229
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Utah
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Salt Lake City, Utah, États-Unis, 84132
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Wisconsin
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Madison, Wisconsin, États-Unis, 53792
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Milwaukee, Wisconsin, États-Unis, 53226
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
oral
Autres noms:
oral
Autres noms:
Intravenous (IV)
Autres noms:
IV and/or oral
|
Comparateur actif: 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
|
oral
Autres noms:
oral
Autres noms:
IV and/or oral
IV
Autres noms:
|
Expérimental: Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
|
oral
Autres noms:
oral
Autres noms:
Intravenous (IV)
Autres noms:
IV and/or oral
|
Comparateur actif: Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
|
oral
Autres noms:
oral
Autres noms:
IV and/or oral
IV
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Overall Patient Incidence of BCAR
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Central Contact, Astellas Pharma Global Development
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents antinéoplasiques immunologiques
- Agents antibactériens
- Antibiotiques, Antinéoplasiques
- Agents antituberculeux
- Antibiotiques, Antituberculeux
- Inhibiteurs de la calcineurine
- Tacrolimus
- Acide mycophénolique
- Basiliximab
- Thymoglobuline
- Sérum antilymphocytaire
- Alemtuzumab
Autres numéros d'identification d'étude
- 20-04-003
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