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

Completed · Phase 2

Conditions studied: Kidney Transplantation

In brief

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

Key facts

Study ID

NCT00543569

Run by

Astellas Pharma Inc

People needed

323

Starts

2008-02-01

Expected to finish

2011-02-01

Last updated by the study team

2015-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
• Subject is a recipient of a de novo kidney transplant
• Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor

You may not qualify if…

• Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of < 250 cells/µL
• Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours
• Recipient has a positive T or B-cell cross match by investigational site's standard method of determination
• Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:
• History of hypertension and a terminal serum creatinine > 1.5 mg/dL
• Cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5 mg/dL
• History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5 mg/dL

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States
• University of Southern California - University Hospital — Los Angeles, California, United States
• St. Vincent/National Institute of Transplantation — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• UCSD — San Diego, California, United States
• California Institute of Renal Research/Sharp Memorial Hospital — San Diego, California, United States
• University of California - San Francisco — San Francisco, California, United States
• University of Colorado Health Science Center — Aurora, Colorado, United States
• University of Florida, Shands Hospital, Gainesville — Gainesville, Florida, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Medical College of Georgia, Augusta — Augusta, Georgia, United States
• Rush - Presbyterian - St. Lukes Medical Center — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Maryland Center — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• St. Barnabas Medical Center — Livingston, New Jersey, United States
• Buffalo General Hospital — Buffalo, New York, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• New York Presbyterian Hospital - Cornell — New York, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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