Clinical trial NCT00543569: A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Keywords: kidney transplant
alefacept
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review
timeFrame: 6 months
Secondary outcomes:
measure: Patient Survival at Month 6 and Month 12
timeFrame: 6 months and 12 months
measure: Graft Survival at Month 6 and Month 12
timeFrame: 6 months and 12 months
measure: Percentage of Participants With BCAR at Month 12 Assessed by Local Review
timeFrame: 12 months
measure: Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review
timeFrame: 6 months and 12 months
measure: Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review
timeFrame: 6 months and 12 months
measure: Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review
timeFrame: 6 months and 12 months
measure: Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12
timeFrame: Week 4, Month 6 and Month 12
measure: Change From Week 4 in GFR by Iothalamate Clearance at Month 6
timeFrame: Week 4 and Month 6
measure: Change From Week 4 in Serum Creatinine at Month 6 and 12
timeFrame: Week 4 and Month 6 and 12
measure: Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review
timeFrame: 6 months and 12 months
measure: Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review
timeFrame: 6 months and 12 months
measure: Time to First BCAR Assessed by Local Review
timeFrame: 12 months
measure: Time to First BCAR Assessed by Central Review
timeFrame: 12 months
measure: Time to First T-cell Mediated BCAR Assessed by Local Review
timeFrame: 12 months
measure: Time to First T-cell Mediated BCAR Assessed by Central Review
timeFrame: 12 months
measure: Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
timeFrame: 6 months and 12 months
measure: Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
timeFrame: 6 months and 12 months
measure: Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12
timeFrame: 6 months and 12 months
measure: Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12
timeFrame: 6 months and 12 months
measure: Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12
timeFrame: 6 months and 12 months
measure: Percentage of Participants With Treatment Failure at Month 6 and 12
timeFrame: 6 months and 12 months
measure: Gastrointestinal Quality of Life Index Score Over Time
timeFrame: Months 1, 3, 6, and 12
measure: Gastrointestinal Symptom Rating Scale Scores Over Time
timeFrame: Months 1, 3, 6, and 12
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California - University Hospital
state: California
city: Los Angeles
country: United States
facility: St. Vincent/National Institute of Transplantation
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: UCSD
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research/Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida, Shands Hospital, Gainesville
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia, Augusta
state: Georgia
city: Chicago
country: United States
facility: Rush - Presbyterian - St. Lukes Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Livingston
country: United States
facility: St. Barnabas Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospital of Cleveland
state: Ohio
city: Portland
country: United States
facility: Legacy Transplant Services
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Harrisburg
country: United States
facility: Pinnacle Health at Harrisburg
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist University Hospital - Memphis
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Methodist Hospital Research Institute of Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Medicine
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: Astellas Pharma Global Development
name: Senior Medical Director
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: