A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
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
1 other identifier
interventional
323
1 country
38
Brief Summary
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
Typical duration for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2007
CompletedFirst Posted
Study publicly available on registry
October 15, 2007
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
December 11, 2015
CompletedDecember 11, 2015
November 1, 2015
3 years
October 11, 2007
November 6, 2015
November 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit.
6 months
Secondary Outcomes (23)
Patient Survival at Month 6 and Month 12
6 months and 12 months
Graft Survival at Month 6 and Month 12
6 months and 12 months
Percentage of Participants With BCAR at Month 12 Assessed by Local Review
12 months
Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review
6 months and 12 months
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review
6 months and 12 months
- +18 more secondary outcomes
Study Arms (4)
Tacrolimus/MMF/Basiliximab
ACTIVE COMPARATORParticipants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
Alefacept QW/Tacrolimus/MMF
EXPERIMENTALParticipants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
Alefacept QW/Tacrolimus
EXPERIMENTALParticipants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
Alefacept QOW/Tacrolimus/MMF
EXPERIMENTALParticipants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
Interventions
Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.
Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
University of Southern California - University Hospital
Los Angeles, California, 90033, United States
St. Vincent/National Institute of Transplantation
Los Angeles, California, 90057, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
UCSD
San Diego, California, 92103, United States
California Institute of Renal Research/Sharp Memorial Hospital
San Diego, California, 92123, United States
University of California - San Francisco
San Francisco, California, 94143, United States
University of Colorado Health Science Center
Aurora, Colorado, 80045, United States
University of Florida, Shands Hospital, Gainesville
Gainesville, Florida, 32610, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Medical College of Georgia, Augusta
Augusta, Georgia, 30921, United States
Rush - Presbyterian - St. Lukes Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Maryland Center
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Buffalo General Hospital
Buffalo, New York, 14203, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
New York Presbyterian Hospital - Cornell
New York, New York, 10065, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University Hospital of Cleveland
Cleveland, Ohio, 44106, United States
Legacy Transplant Services
Portland, Oregon, 97210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, 17101, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Methodist University Hospital - Memphis
Memphis, Tennessee, 38104, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Methodist Hospital Research Institute of Houston
Houston, Texas, 77030, United States
University of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Head Global Medical Sciences--Transplant and Immunology/Inflammation
- Organization
- Astellas Pharma Global Development, Inc. (APGD)
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development
- PRINCIPAL INVESTIGATOR
Principal Investigator
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2007
First Posted
October 15, 2007
Study Start
February 1, 2008
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
December 11, 2015
Results First Posted
December 11, 2015
Record last verified: 2015-11