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

November 19, 2025 updated by: Astellas Pharma Global Development, Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Site US10006
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Site US10024
    • California
      • Los Angeles, California, United States, 90057
        • Site US10008
      • Palo Alto, California, United States, 94304
        • Site US10021
      • San Diego, California, United States, 92123
        • Site US10030
      • San Francisco, California, United States, 94115
        • Site US10004
      • San Francisco, California, United States, 94143
        • Site US10003
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Site US10013
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Site US10007
      • Augusta, Georgia, United States, 30912
        • Site US10041
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Site US10010
      • Chicago, Illinois, United States, 60612
        • Site US10018
      • Chicago, Illinois, United States, 60637
        • Site US10037
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Site US10015
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Site US10045
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Site US10014
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Site US10017
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Site US10025
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Site US10022
    • New York
      • Buffalo, New York, United States, 14215
        • Site US10031
      • New York, New York, United States, 10029
        • Site US10034
      • New York, New York, United States, 10065
        • Site US10023
      • The Bronx, New York, United States, 10467
        • Site US10019
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Site US10036
      • Charlotte, North Carolina, United States, 28203
        • Site US10042
      • Durham, North Carolina, United States, 27710
        • Site US10016
      • Greenville, North Carolina, United States, 27834
        • Site US10026
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Site US10009
      • Cleveland, Ohio, United States, 44106
        • Site US10040
      • Cleveland, Ohio, United States, 44195
        • Site US10032
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17011
        • Site US10027
      • Pittsburgh, Pennsylvania, United States, 15213
        • Site US10038
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Site US10012
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Site US10028
      • Nashville, Tennessee, United States, 37232-4750
        • Site US10035
    • Texas
      • Dallas, Texas, United States, 75246
        • Site US10001
      • Fort Worth, Texas, United States, 76104
        • Site US10002
      • Houston, Texas, United States, 77030
        • Site US10029
      • Houston, Texas, United States, 77030
        • Site US10044
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Site US10033
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Site US10020
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Site US10005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of Care
Basiliximab induction + Tacrolimus + MMF + Corticosteroids
Drug: Prednisone
Oral
Drug: Tacrolimus
intravenous or oral
Other Names:
  • Prograf®
Drug: Mycophenolate Mofetil (MMF)
intravenous or oral
Other Names:
  • CellCept®
Drug: Basiliximab
intravenous
Other Names:
  • Simulect®
Drug: Methylprednisone
Intravenous
Experimental: CNI avoidance
Basiliximab induction + ASKP1240 + MMF + Corticosteroids
Drug: Prednisone
Oral
Drug: Mycophenolate Mofetil (MMF)
intravenous or oral
Other Names:
  • CellCept®
Drug: Basiliximab
intravenous
Other Names:
  • Simulect®
Drug: Methylprednisone
Intravenous
Drug: ASKP1240
intravenous infusion
Experimental: CNI minimization-MMF avoidance
Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids
Drug: Prednisone
Oral
Drug: Tacrolimus
intravenous or oral
Other Names:
  • Prograf®
Drug: Basiliximab
intravenous
Other Names:
  • Simulect®
Drug: Methylprednisone
Intravenous
Drug: ASKP1240
intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glomerular Filtration Rate (GFR)
Time Frame: 6 months
GFR is based on Modification of Diet in Renal Disease (4 variable-MDRD) criteria
6 months
Patient Survival
Time Frame: 6 months
Subject survival is defined as any subject who does not die during the study.
6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Global Development, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kyowa Kirin Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Senior Medical Director, Astellas Pharma Global Development, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2013

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7163-CL-0108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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