Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01780844
Recruitment Status : Completed
First Posted : January 31, 2013
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
Kyowa Kirin Co., Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Tracking Information
First Submitted Date  ICMJE January 29, 2013
First Posted Date  ICMJE January 31, 2013
Last Update Posted Date April 21, 2017
Actual Study Start Date  ICMJE March 5, 2013
Actual Primary Completion Date June 30, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
  • Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ]
    GFR is based on Modification of Diet in Renal Disease (4 variable-MDRD) criteria
  • Patient Survival [ Time Frame: 6 months ]
    Subject survival is defined as any subject who does not die during the study.
  • Graft Survival [ Time Frame: 6 months ]
    Graft survival is defined as any subject who does not experience graft loss during the study. Graft loss is defined as subject death, retransplantation, transplant nephrectomy, or the permanent return to dialysis (greater than 30 days).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Official Title  ICMJE A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Brief Summary The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids [calcineurin inhibitor (CNI) avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids [CNI minimization-MMF avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).
Detailed Description Subjects will be followed for 6 months. Upon completion of the first 6 months of the study, subjects may participate in the Long Term Extension period of the study. Subjects will remain on their original treatment arm up to three years post-transplant (and / or Sponsor discontinues development or the subject no longer wishes to participate in the study).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplantation
Intervention  ICMJE
  • Drug: ASKP1240
    intravenous infusion
  • Drug: Tacrolimus
    intravenous or oral
    Other Name: Prograf®
  • Drug: Mycophenolate Mofetil (MMF)
    intravenous or oral
    Other Name: CellCept®
  • Drug: Basiliximab
    intravenous
    Other Name: Simulect®
  • Drug: Methylprednisone
    Intravenous
  • Drug: Prednisone
    Oral
Study Arms  ICMJE
  • Active Comparator: Standard of Care
    Basiliximab induction + Tacrolimus + MMF + Corticosteroids
    Interventions:
    • Drug: Tacrolimus
    • Drug: Mycophenolate Mofetil (MMF)
    • Drug: Basiliximab
    • Drug: Methylprednisone
    • Drug: Prednisone
  • Experimental: CNI avoidance
    Basiliximab induction + ASKP1240 + MMF + Corticosteroids
    Interventions:
    • Drug: ASKP1240
    • Drug: Mycophenolate Mofetil (MMF)
    • Drug: Basiliximab
    • Drug: Methylprednisone
    • Drug: Prednisone
  • Experimental: CNI minimization-MMF avoidance
    Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids
    Interventions:
    • Drug: ASKP1240
    • Drug: Tacrolimus
    • Drug: Basiliximab
    • Drug: Methylprednisone
    • Drug: Prednisone
Publications * Harland RC, Klintmalm G, Jensik S, Yang H, Bromberg J, Holman J, Kumar MSA, Santos V, Larson TJ, Wang X. Efficacy and safety of bleselumab in kidney transplant recipients: A phase 2, randomized, open-label, noninferiority study. Am J Transplant. 2020 Jan;20(1):159-171. doi: 10.1111/ajt.15591. Epub 2019 Oct 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2014)
149
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2013)
126
Actual Study Completion Date  ICMJE January 27, 2017
Actual Primary Completion Date June 30, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is a recipient of a de novo kidney from a living or deceased donor

Exclusion Criteria:

  • Subject has induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen
  • Subject has previously received or is receiving an organ transplant other than a kidney
  • Subject will receive a solitary kidney from a deceased donor < 5 years of age
  • Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours
  • Subject will receive a kidney that meets both Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. Note: a kidney that meets either ECD or DCD criteria is eligible for inclusion
  • Subject will receive an ABO incompatible donor kidney
  • Subject has a current calculated panel reactive antibody (cPRA) level >50%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01780844
Other Study ID Numbers  ICMJE 7163-CL-0108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Kyowa Kirin Co., Ltd.
Investigators  ICMJE
Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date April 2017

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