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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2008
End Date:February 2011

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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

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

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

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
38
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San Francisco, California 94143
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Sacramento, California 95814
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San Diego, California 92103
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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1430 John Wesley Gilbert Drive
Augusta, Georgia 30921
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1420 North Charles Street
Baltimore, Maryland 21201
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Buffalo, New York
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Cleveland, Ohio 44106
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1515 Southwest Archer Road
Gainesville, Florida 32610
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Harrisburg, Pennsylvania 17104
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Jacksonville, Florida 32216
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Lexington, Kentucky
859) 257-9000
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Livingston, New Jersey 07039
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
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Madison, Wisconsin 53792
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Memphis, Tennessee 38104
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New York, New York 10021
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New York, New York 10029
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Portland, Oregon 97210
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Salt Lake City, Utah 84132
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Valhalla, New York 10595
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