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

This study has been completed.
Sponsor:
Collaborator:
Kyowa Hakko Kirin Co., Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01780844
First received: January 29, 2013
Last updated: April 20, 2017
Last verified: April 2017
  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: Methylprednisone
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • 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).


Enrollment: 149
Actual Study Start Date: March 5, 2013
Study Completion Date: January 27, 2017
Primary Completion Date: June 30, 2014 (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: Methylprednisone
Intravenous
Drug: Prednisone
Oral
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: Methylprednisone
Intravenous
Drug: Prednisone
Oral
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: Methylprednisone
Intravenous
Drug: Prednisone
Oral

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   (Adult, Senior)
Sexes Eligible for Study:   All
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 Co., Ltd
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.
  More Information

Responsible Party: 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: April 20, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Tacrolimus
Basiliximab
Mycophenolate mofetil
Mycophenolic Acid
Prednisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 23, 2017