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 |
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.
patients.
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de
novo kidney transplant recipients.
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
sites
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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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
Portland, Oregon 97239
503 494-8311
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Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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University of Illinois at Chicago A major research university in the heart of one of...
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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
Gainesville, Florida 32610
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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