- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00617604
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Bruxelles, Belgien, 1070
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Bruxelles, Belgien, 1200
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Gent, Belgien, 9000
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Leuven, Belgien, 3000
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Liege, Belgien, 4000
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Bochum, Deutschland, 44892
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Regensburg, Deutschland, 93053
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Creteil, Frankreich, 94010
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Le Kremlin Bicetre Cedex, Frankreich, 94275
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Montpellier, Frankreich, 34295
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Nantes Cedex 1, Frankreich, 44093
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Nice Cedex 1, Frankreich, 6002
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Paris, Frankreich, 75475
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Toulouse Cedex, Frankreich, 31054
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Bologna, Italien, 40138
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Padova, Italien, 35128
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Rome, Italien, 00168
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Siena, Italien, 53100
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Maastricht, Niederlande, 6229
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Bydgoszcz, Polen, 85-094
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Poznan, Polen, 60-479
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Szczecin, Polen, 70-111
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Goteborg, Schweden, 41345
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Uppsala, Schweden, 75185
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Barcelona, Spanien, 8036
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Llobregat, Spanien, 8907
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Madrid, Spanien, 28041
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Malaga, Spanien, 29010
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Santander, Spanien, 39008
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Praha, Tschechische Republik, 140 21
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Budapest, Ungarn, 1082
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Manchester, Vereinigtes Königreich, M13 9WL
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Vienna, Österreich, 1090
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or retransplantation
- Male or female subject at least 18 years of age and younger than 65 years
- Subject receiving a kidney transplant from a non-human leucocyte antigen (HLA) identical living donor or deceased HLA identical/non-HLA identical donor between 5 and 59 years of age with compatible ABO blood type (Blood group system A, B, AB and 0)
Exclusion Criteria:
- Subject has a panel reactivity antibody grade > 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons
- Subject received a kidney transplant from a non-heart beating donor
- Subject has received a kidney transplant from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine > 1.5 mg/dL (united network for organ sharing [UNOS] expanded criteria donor)
- Cold ischemia time of the donor kidney is ≥ 30 hours
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Placebo-Komparator: Placebo
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks.
Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
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IV and subcutaneous injection
The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.
Mycophenolic mofetil was administered as 750 mg twice per day orally
Methylprednisolone or equivalent: Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus Prednisone or equivalent: Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally |
Experimental: Alefacept
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks.
Participants also received tacrolimus, MMF and steroid treatment.
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The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.
Mycophenolic mofetil was administered as 750 mg twice per day orally
Methylprednisolone or equivalent: Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus Prednisone or equivalent: Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally
IV and subcutaneous injection
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review
Zeitfenster: 6 months
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Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. |
6 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6
Zeitfenster: 6 months
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Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification: Acute antibody-mediated rejection - documented anti-donor antibody ('suspicious for' if antibody not demonstrated):
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. |
6 months
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Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6
Zeitfenster: 6 months
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Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. |
6 months
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Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6
Zeitfenster: 6 months
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Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. |
6 months
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Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6
Zeitfenster: 6 months
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Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection).
The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported.
Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
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6 months
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Percentage of Participants With Clinically Treated Acute Rejection at Month 6
Zeitfenster: 6 months
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Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection.
The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported.
Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
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6 months
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Percentage of Participants With Steroid-resistant Acute Rejection at Month 6
Zeitfenster: 6 months
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A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category. The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. |
6 months
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Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6
Zeitfenster: 6 months
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Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. |
6 months
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Patient Survival
Zeitfenster: 6 months
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Patient survival is any participant known to be alive at Month 6.
The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported.
Participants lost to follow-up were censored at the time of last assessment.
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6 months
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Graft Survival
Zeitfenster: 6 months
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Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information. The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment. |
6 months
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Maximum Histological Grade of All Biopsies After Local Review
Zeitfenster: 6 months
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The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used. Acute T-cell mediated rejection:
Acute antibody-mediated rejection:
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6 months
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Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6
Zeitfenster: 6 months
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The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported.
Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
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6 months
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Change From Month 1 in Serum Creatinine
Zeitfenster: Month 1, 3, and 6
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Month 1, 3, and 6
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Change From Month 1 in Glomerular Filtration Rate (GFR)
Zeitfenster: Month 1, 3, and 6
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The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
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Month 1, 3, and 6
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Change From Month 1 in Creatinine Clearance
Zeitfenster: Month 1, 3, and 6
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The creatinine clearance was calculated according to the Cockcroft-Gault formula.
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Month 1, 3, and 6
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GFR Measured by Iothalamate Clearance at Month 6
Zeitfenster: Month 6
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GFR measured using the iothalamate clearance method and determined by a central laboratory.
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Month 6
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Percentage of Participants With Efficacy Failure at Month 6
Zeitfenster: 6 months
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Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up. The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported. |
6 months
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Percentage of Participants With Delayed Graft Function
Zeitfenster: 1 week
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Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.
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1 week
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Percentage of Participants With Treatment Failure at Month 6
Zeitfenster: 6 months
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Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason.
The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported.
Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
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6 months
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Number of Participants With Adverse Events
Zeitfenster: 6 Months
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Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose:
All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE |
6 Months
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche 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
- Dermatologische Wirkstoffe
- Antibakterielle Mittel
- Antibiotika, antineoplastische
- Antituberkulöse Mittel
- Antibiotika, Antituberkulose
- Calcineurin-Inhibitoren
- Tacrolimus
- Mycophenolsäure
- Alefacept
Andere Studien-ID-Nummern
- 0485-CL-E201
- 2007-002092-14 (EudraCT-Nummer)
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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