NCT00543569

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

A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.

Detailed description

This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Alefacept	Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
DRUG	tacrolimus	The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
DRUG	basiliximab	Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.
DRUG	mycophenolate mofetil	Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
DRUG	Corticosteroids	Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2007-10-15
• Last updated: 2015-12-11
• Results posted: 2015-12-11

Locations

38 sites across 1 country: United States