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

January 4, 2024 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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

149

Phase

  • 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
      • Saint Louis, Missouri, United States, 63110
        • Site US10025
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Site US10022
    • New York
      • Bronx, New York, United States, 10467
        • Site US10019
      • 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
    • 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

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
Intervention / Treatment
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

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

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

Astellas Pharma Global Development, Inc.

Collaborators

Kyowa Kirin Co., Ltd.

Investigators

  • 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)

March 5, 2013

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

January 27, 2017

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimated)

January 31, 2013

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7163-CL-0108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Kidney Transplantation

Clinical Trials on Prednisone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe