Trial record 1 of 1 for:    NCT00543569
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A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00543569
First received: October 11, 2007
Last updated: February 26, 2013
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Kidney Transplantation
Drug: Alefacept
Drug: tacrolimus
Drug: basiliximab
Drug: mycophenolate mofetil
Drug: steroids
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of biopsy-confirmed acute rejection (BCAR) assessed by local review [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient and graft survival rates [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • BCAR rate by local review [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Serum creatinine [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Glomerular filtration rate (GFR) by Modification of Diet in Renal disease (MDRD) method [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • GFR by iothalamate clearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of efficacy failure (based local review of biopsy) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Incidence of efficacy failure (based on central review of biopsy) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Time to first BCAR as assessed by local review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of clinically-treated acute rejections [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Use of anti-lymphocyte antibody therapy for treatment of rejection [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Incidence of patients experiencing multiple rejection episodes [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Incidence of treatment failure [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Incidence of BCAR assessed by central review [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Time to first BCAR, as assessed by central review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of T-cell mediated BCAR assessed by local review [ Time Frame: 6 montha and 12 months ] [ Designated as safety issue: No ]
  • Incidence of T-cell mediated BCAR assessed by central review [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Time to first T-cell mediated BCAR as assessed by local review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to first T-cell mediated BCAR as assessed by central review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Maximum grade of T-cell mediated rejection as assessed by local review [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Maximum grade of T-cell mediated rejection as assessed by central review [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 323
Study Start Date: December 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Comparator Regimen
tacrolimus, basiliximab, MMF, steroids
Drug: tacrolimus
Oral
Other Name: Prograf, FK506
Drug: basiliximab
IV
Other Name: Simulect
Drug: mycophenolate mofetil
Oral
Other Name: CellCept, MMF
Drug: steroids
Oral
Experimental: 2. CNI Reduction
alefacept, tacrolimus, MMF, steroids
Drug: Alefacept
IV and Sub-cutaneous
Other Name: Amevive, ASP0485
Drug: tacrolimus
Oral
Other Name: Prograf, FK506
Drug: mycophenolate mofetil
Oral
Other Name: CellCept, MMF
Drug: steroids
Oral
Experimental: 3. MMF Replacement
alefacept, tacrolimus, steroids
Drug: Alefacept
IV and Sub-cutaneous
Other Name: Amevive, ASP0485
Drug: tacrolimus
Oral
Other Name: Prograf, FK506
Drug: steroids
Oral
Experimental: 4. Alternative Alefacept Dosing
alefacept, tacrolimus, MMF, steroids
Drug: Alefacept
IV and Sub-cutaneous
Other Name: Amevive, ASP0485
Drug: tacrolimus
Oral
Other Name: Prograf, FK506
Drug: mycophenolate mofetil
Oral
Other Name: CellCept, MMF
Drug: steroids
Oral

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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-HLA identical related living donor, a non-related living donor, or a deceased donor

Exclusion Criteria:

  • Subject has a screening (pre-operative)estimated CD4+ T cell count of <250 cells/uL
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543569

  Hide Study Locations
Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
St. Vincent/National Institute of Transplantation
Los Angeles, California, United States, 90057
University of Southern California - University Hospital
Los Angeles, California, United States, 90033
UC Davis Medical Center
Sacramento, California, United States, 95817
California Institute of Renal Research/Sharp Memorial Hospital
San Diego, California, United States, 92123
UCSD
San Diego, California, United States, 92103
University of California - San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Health Science Center
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida, Shands Hospital, Gainesville
Gainesville, Florida, United States, 32610
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
Medical College of Georgia, Augusta
Augusta, Georgia, United States, 30921
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Rush - Presbyterian - St. Lukes Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
University of Maryland Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Buffalo General Hospital
Buffalo, New York, United States, 14203
New York Presbyterian Hospital - Cornell
New York, New York, United States, 10065
Mt. Sinai School of Medicine
New York, New York, United States, 10029
Westchester Medical Center
Valhalla, New York, United States, 10595
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
Legacy Transplant Services
Portland, Oregon, United States, 97210
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, United States, 17101
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Methodist University Hospital - Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Methodist Hospital Research Institute of Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development
Principal Investigator: Principal Investigator University of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00543569     History of Changes
Other Study ID Numbers: 0485-CL-U201
Study First Received: October 11, 2007
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
kidney transplant
alefacept

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Basiliximab
Alefacept
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2014