NCT00147381 - Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection | Biotech Hunter

Enrollment

197

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

August 31, 2008

Study Completion Date

July 31, 2011

Conditions

Kidney Transplantation

Interventions

DRUG

Alemtuzumab

"Day 0: Campath-1H 20 mg IV infusion over 3-6 hours~Day 1: Campath-1H 20 mg IV infusion over 3-6 hours"

DRUG

Tacrolimus

"Day 0: Tacrolimus will be given pre-operatively or immediately post transplant surgery. The recommended initial daily starting dose is 0,1 mg/kg/d orally (0,05 mg/kg/bid) to aim at a whole blood level of 8-12 ng/ml.~till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months).~Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months."

DRUG

Alemtuzumab

"Day 0: Campath-1H 30 mg IV infusion over 3-6 hours~Day 1: Campath-1H 30 mg IV infusion over 3-6 hours"

Trial Locations (1)

6020

University Hospital Innsbruck, Innsbruck