Clinical trial NCT00617604: A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: De Novo Kidney Transplantation
Keywords: kidney transplant
alefacept
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6
timeFrame: 6 months
measure: Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6
timeFrame: 6 months
measure: Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6
timeFrame: 6 months
measure: Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6
timeFrame: 6 months
measure: Percentage of Participants With Clinically Treated Acute Rejection at Month 6
timeFrame: 6 months
measure: Percentage of Participants With Steroid-resistant Acute Rejection at Month 6
timeFrame: 6 months
measure: Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6
timeFrame: 6 months
measure: Patient Survival
timeFrame: 6 months
measure: Graft Survival
timeFrame: 6 months
measure: Maximum Histological Grade of All Biopsies After Local Review
timeFrame: 6 months
measure: Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6
timeFrame: 6 months
measure: Change From Month 1 in Serum Creatinine
timeFrame: Month 1, 3, and 6
measure: Change From Month 1 in Glomerular Filtration Rate (GFR)
timeFrame: Month 1, 3, and 6
measure: Change From Month 1 in Creatinine Clearance
timeFrame: Month 1, 3, and 6
measure: GFR Measured by Iothalamate Clearance at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Efficacy Failure at Month 6
timeFrame: 6 months
measure: Percentage of Participants With Delayed Graft Function
timeFrame: 1 week
measure: Percentage of Participants With Treatment Failure at Month 6
timeFrame: 6 months
measure: Number of Participants With Adverse Events
timeFrame: 6 Months
Other outcomes:
Locations:
city: Vienna
country: Austria
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Praha
country: Czech Republic
city: Creteil
country: France
city: Le Kremlin Bicetre Cedex
country: France
city: Montpellier
country: France
city: Nantes Cedex 1
country: France
city: Nice Cedex 1
country: France
city: Paris
country: France
city: Toulouse Cedex
country: France
city: Bochum
country: Germany
city: Regensburg
country: Germany
city: Budapest
country: Hungary
city: Bologna
country: Italy
city: Padova
country: Italy
city: Rome
country: Italy
city: Siena
country: Italy
city: Maastricht
country: Netherlands
city: Bydgoszcz
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Barcelona
country: Spain
city: Llobregat
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Santander
country: Spain
city: Goteborg
country: Sweden
city: Uppsala
country: Sweden
city: Manchester
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_CHAIR
References: