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Trial record 5 of 18 for:    askp

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. )

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).

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: ASKP1240 Drug: Tacrolimus Drug: Mycophenolate Mofetil (MMF) Drug: Basiliximab Drug: Methylprednisone Drug: Prednisone Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 5, 2013
Actual Primary Completion Date : June 30, 2014
Actual Study Completion Date : January 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ]
    GFR is based on Modification of Diet in Renal Disease (4 variable-MDRD) criteria

  2. Patient Survival [ Time Frame: 6 months ]
    Subject survival is defined as any subject who does not die during the study.

  3. 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).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780844


Locations
Show Show 42 study locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Kyowa Kirin Co., Ltd.
Investigators
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Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT01780844    
Other Study ID Numbers: 7163-CL-0108
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Kidney Transplantation
de novo Kidney Transplantation
ASKP1240
Additional relevant MeSH terms:
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Mycophenolic Acid
Prednisone
Tacrolimus
Basiliximab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents