A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients

PHASE2CompletedINTERVENTIONAL
Enrollment

218

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
De Novo Kidney Transplantation
Interventions
DRUG

Alefacept

IV and subcutaneous injection

DRUG

placebo

IV and subcutaneous injection

DRUG

Tacrolimus

The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.

DRUG

Mycophenolate Mofetil

Mycophenolic mofetil was administered as 750 mg twice per day orally

DRUG

Steroids

"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"

Trial Locations (33)

1070

Brussels

1082

Budapest

1090

Vienna

1200

Brussels

3000

Leuven

4000

Liège

6002

Nice

6229

Maastricht

8036

Barcelona

8907

Llobregat

9000

Ghent

28041

Madrid

29010

Málaga

31054

Toulouse

34295

Montpellier

35128

Padua

39008

Santander

40138

Bologna

41345

Gothenburg

44093

Nantes

44892

Bochum

53100

Siena

75185

Uppsala

75475

Paris

93053

Regensburg

94010

Créteil

94275

Le Kremlin-Bicêtre

140 21

Prague

00168

Rome

85-094

Bydgoszcz

60-479

Poznan

70-111

Szczecin

M13 9WL

Manchester

Sponsors
All Listed Sponsors
lead

Astellas Pharma Inc

INDUSTRY

NCT00617604 - A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients | Biotech Hunter | Biotech Hunter