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Completed

NCT Number: NCT01780844

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

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).

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site US10006, Birmingham, Alabama, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

ASKP1240

Drug

intravenous infusion

Tacrolimus

Drug

intravenous or oral

Other names: Prograf®

Mycophenolate Mofetil (MMF)

Drug

intravenous or oral

Other names: CellCept®

Basiliximab

Drug

intravenous

Other names: Simulect®

Methylprednisone

Drug

Intravenous

Prednisone

Drug

Oral

Primary outcomes

  1. Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review

    Time frame: 6 months

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Collaborators

  • Kyowa Kirin Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Jan 31, 2013
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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