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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kyowa Hakko Kirin Company, Limited
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01780844
First received: January 29, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Kidney Transplantation
Drug: ASKP1240
Drug: Tacrolimus
Drug: Mycophenolate Mofetil (MMF)
Drug: Basiliximab
Drug: Corticosteroids
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 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    GFR is based on Modification of Diet in Renal Disease (4 variable-MDRD) criteria

  • Patient Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Subject survival is defined as any subject who does not die during the study.

  • Graft Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 149
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care
Basiliximab induction + Tacrolimus + MMF + Corticosteroids
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: Corticosteroids
intravenous or oral
Other Name: Methylprednisone, Prednisone
Experimental: CNI avoidance
Basiliximab induction + ASKP1240 + MMF + Corticosteroids
Drug: ASKP1240
intravenous infusion
Drug: Mycophenolate Mofetil (MMF)
intravenous or oral
Other Name: CellCept®
Drug: Basiliximab
intravenous
Other Name: Simulect®
Drug: Corticosteroids
intravenous or oral
Other Name: Methylprednisone, Prednisone
Experimental: CNI minimization-MMF avoidance
Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids
Drug: ASKP1240
intravenous infusion
Drug: Tacrolimus
intravenous or oral
Other Name: Prograf®
Drug: Basiliximab
intravenous
Other Name: Simulect®
Drug: Corticosteroids
intravenous or oral
Other Name: Methylprednisone, Prednisone

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  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: NCT01780844

  Show 42 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT01780844     History of Changes
Other Study ID Numbers: 7163-CL-0108
Study First Received: January 29, 2013
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
de novo Kidney Transplantation
Kidney Transplantation
ASKP1240

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

ClinicalTrials.gov processed this record on July 26, 2014