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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

October 11, 2007
February 26, 2013
December 2007
January 2011   (final data collection date for primary outcome measure)
Incidence of biopsy-confirmed acute rejection (BCAR) assessed by local review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To assess the safety and efficacy of alefacept in kidney transplantation [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00543569 on ClinicalTrials.gov Archive Site
  • 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 ]
To assess the safety and efficacy of different alefacept dosing regimens [ Time Frame: 12 months ]
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: Alefacept
    IV and Sub-cutaneous
    Other Name: Amevive, ASP0485
  • Drug: tacrolimus
    Oral
    Other Name: Prograf, FK506
  • Drug: basiliximab
    IV
    Other Name: Simulect
  • Drug: mycophenolate mofetil
    Oral
    Other Name: CellCept, MMF
  • Drug: steroids
    Oral
  • Active Comparator: 1. Comparator Regimen
    tacrolimus, basiliximab, MMF, steroids
    Interventions:
    • Drug: tacrolimus
    • Drug: basiliximab
    • Drug: mycophenolate mofetil
    • Drug: steroids
  • Experimental: 2. CNI Reduction
    alefacept, tacrolimus, MMF, steroids
    Interventions:
    • Drug: Alefacept
    • Drug: tacrolimus
    • Drug: mycophenolate mofetil
    • Drug: steroids
  • Experimental: 3. MMF Replacement
    alefacept, tacrolimus, steroids
    Interventions:
    • Drug: Alefacept
    • Drug: tacrolimus
    • Drug: steroids
  • Experimental: 4. Alternative Alefacept Dosing
    alefacept, tacrolimus, MMF, steroids
    Interventions:
    • Drug: Alefacept
    • Drug: tacrolimus
    • Drug: mycophenolate mofetil
    • Drug: steroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00543569
0485-CL-U201
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Senior Medical Director Astellas Pharma Global Development
Principal Investigator: Principal Investigator University of Michigan
Astellas Pharma Inc
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP