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Kidney TransplantationPhase 2NCT01780844

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

A Phase 2 study testing ASKP1240, Tacrolimus and Mycophenolate Mofetil (MMF) in people with Kidney Transplantation, run by Astellas Pharma Global Development, Inc. at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplantation
What is being tested?
ASKP1240, Tacrolimus and Mycophenolate Mofetil (MMF)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
42 sitesUnited States
Study dates
5 Mar 2013to 27 Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is a recipient of a de novo kidney from a living or deceased donor

Who cannot join

  • 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%

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • Site US10017

    Ann Arbor, Michigan, 48109

  • Site US10007

    Atlanta, Georgia, 30322

  • Site US10041

    Augusta, Georgia, 30912

  • Site US10013

    Aurora, Colorado, 80045

  • Site US10014

    Baltimore, Maryland, 21201

  • Site US10006

    Birmingham, Alabama, 35233

  • Site US10031

    Buffalo, New York, 14215

  • Site US10036

    Chapel Hill, North Carolina, 27599

  • Site US10012

    Charleston, South Carolina, 29425

  • Site US10042

    Charlotte, North Carolina, 28203

  • Site US10020

    Charlottesville, Virginia, 22908

  • Site US10010

    Chicago, Illinois, 60612

  • Site US10018

    Chicago, Illinois, 60612

  • Site US10037

    Chicago, Illinois, 60637

  • Site US10009

    Cincinnati, Ohio, 45267

  • Site US10040

    Cleveland, Ohio, 44106

  • Site US10032

    Cleveland, Ohio, 44195

  • Site US10001

    Dallas, Texas, 75246

  • Site US10016

    Durham, North Carolina, 27710

  • Site US10002

    Fort Worth, Texas, 76104

  • Site US10026

    Greenville, North Carolina, 27834

  • Site US10027

    Harrisburg, Pennsylvania, 17011

  • Site US10029

    Houston, Texas, 77030

  • Site US10044

    Houston, Texas, 77030

  • Site US10015

    Lexington, Kentucky, 40536

  • Site US10022

    Livingston, New Jersey, 07039

  • Site US10008

    Los Angeles, California, 90057

  • Site US10005

    Madison, Wisconsin, 53792

  • Site US10028

    Memphis, Tennessee, 38104

  • Site US10035

    Nashville, Tennessee, 37232-4750

  • Site US10045

    New Orleans, Louisiana, 70112

  • Site US10034

    New York, New York, 10029

  • Site US10023

    New York, New York, 10065

  • Site US10021

    Palo Alto, California, 94304

  • Site US10024

    Phoenix, Arizona, 85054

  • Site US10038

    Pittsburgh, Pennsylvania, 15213

  • Site US10033

    Salt Lake City, Utah, 84132

  • Site US10030

    San Diego, California, 92123

  • Site US10004

    San Francisco, California, 94115

  • Site US10003

    San Francisco, California, 94143

  • Site US10025

    St Louis, Missouri, 63110

  • Site US10019

    The Bronx, New York, 10467

Other trials in United States

About this study

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

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).

Read the 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).

Being tested
ASKP1240, Tacrolimus, Mycophenolate Mofetil (MMF), Basiliximab, Methylprednisone
Keywords
Kidney Transplantation, de novo Kidney Transplantation, ASKP1240

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASKP1240Drug

    intravenous infusion

  • TacrolimusDrug

    Also called Prograf®

    intravenous or oral

  • Mycophenolate Mofetil (MMF)Drug

    Also called CellCept®

    intravenous or oral

  • BasiliximabDrug

    Also called Simulect®

    intravenous

  • MethylprednisoneDrug

    Intravenous

  • PrednisoneDrug

    Oral

Study groups in NCT01780844
Study groupRoleWhat they receive
Standard of CareActive comparatorBasiliximab induction + Tacrolimus + MMF + Corticosteroids
Receives: Drug: Tacrolimus; Drug: Mycophenolate Mofetil (MMF); Drug: Basiliximab; Drug: Methylprednisone; Drug: Prednisone
CNI avoidanceExperimentalBasiliximab induction + ASKP1240 + MMF + Corticosteroids
Receives: Drug: ASKP1240; Drug: Mycophenolate Mofetil (MMF); Drug: Basiliximab; Drug: Methylprednisone; Drug: Prednisone
CNI minimization-MMF avoidanceExperimentalBasiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids
Receives: Drug: ASKP1240; Drug: Tacrolimus; Drug: Basiliximab; Drug: Methylprednisone; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (3)

  1. Glomerular Filtration Rate (GFR)

    GFR is based on Modification of Diet in Renal Disease (4 variable-MDRD) criteria

    Measured: 6 months

  2. Patient Survival

    Subject survival is defined as any subject who does not die during the study.

    Measured: 6 months

  3. Graft Survival

    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).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2013 (estimated)
  2. Study start5 Mar 2013
  3. Primary completion30 Jun 2014
  4. Study completion27 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01780844
Sponsor's protocol ID
7163-CL-0108
Status last verified
Nov 2025
First submitted
29 Jan 2013
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Harland RC, Klintmalm G, Jensik S, Yang H, Bromberg J, Holman J, Kumar MSA, Santos V, Larson TJ, Wang X. Efficacy and safety of bleselumab in kidney transplant recipients: A phase 2, randomized, open-label, noninferiority study. Am J Transplant. 2020 Jan;20(1):159-171. doi: 10.1111/ajt.15591. Epub 2019 Oct 19.

    PubMed 31509331

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASKP1240, Tacrolimus and Mycophenolate Mofetil (MMF) in people with Kidney Transplantation, run by Astellas Pharma Global Development, Inc. at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01780844, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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