A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation

A Phase 1b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Single-Dose, Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of ASKP1240 in de Novo Kidney Transplantation

The purpose of the study is to assess the Pharmacokinetics (PK),

pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Placebo; Drug: bleselumab

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
    • San Diego, California, United States, 92123
      • California Institute of Renal Research
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
    • San Francisco, California, United States, 94143
      • UCSF Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Medical Center
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center, The Transplant Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • St. Barnabas Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati - University Internal Medicine Associates
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17104
      • Central Pennsylvania Transplant Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is a recipient of a de novo kidney transplant from a living or deceased donor
• Prior to randomization, the subject has a post-transplant serum creatinine value that is at least 30% decreased from the pre-transplant value and requires no dialysis
• Female subject of child bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment or upon hospitalization and must agree to maintain effective birth control during the study
• All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agrees to no sperm donation until the end of the study, or for 90 days after the last dose of study drug, whichever is longer
• Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions

Exclusion Criteria:

• Prior to randomization, subject will receive antibody induction therapy (e.g., thymoglobulin, basiliximab, daclizumab, OKT3, alemtuzumab)
• Subject has previously received or is receiving an organ transplant other than a kidney
• Recipient has a positive T or B cell crossmatch
• Subject has ABO blood type incompatibility with their donor
• Subject has received intravenous immunoglobulin (IVIG) therapy in the 3 months prior to first dose of study drug
• Recipient or donor is known by medical history to be seropositive for human immunodeficiency virus (HIV)
• Subject had a thromboembolic event (e.g., myocardial infarction, cerebrovascular event, pulmonary embolus, deep vein thrombosis, peripheral arterial thromboembolic event) in the past 5 years or if the subject is on specific therapy for prophylaxis or treatment of such an event. Low dose aspirin (81 mg) therapy is not considered exclusionary. NOTE: A one-time event of arterio-venous (AV) fistula dialysis access thrombosis is not exclusionary. Subjects with recurrent AV fistula thrombosis or those on systemic medications to prevent reoccurrence are excluded
• Subject has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
• Subject has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
• Subject is concurrently participating in another drug study or has received an investigational drug up to 8 weeks (depending on medication) prior to transplant
• Subject has previously received ASKP1240 or participated in a study involving ASKP1240
• Subject has abnormal chest x-ray indicative of acute or chronic lung disease on a prior examination within 3 months prior to randomization
• Subject has abnormal electrocardiogram (ECG) considered as clinically significant on a prior examination within 3 months prior to randomization
• Subject has uncontrolled intercurrent illness, including, but not limited to ongoing or active infection, any clinically significant cardiac disease, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements
• Subject has received live or live attenuated virus vaccinations within the last 30 days prior to first dose of study drug
• Subject has a clinical condition which would not allow safe conduct and completion of the study
• Subject is pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASKP1240 lowest dose; Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.	Drug: bleselumab; Intravenous (IV) infusion; Other Names: ASKP1240
Experimental: ASKP1240 low dose; Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.	Drug: bleselumab; Intravenous (IV) infusion; Other Names: ASKP1240
Experimental: ASKP1240 high dose; Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.	Drug: bleselumab; Intravenous (IV) infusion; Other Names: ASKP1240
Experimental: ASKP1240 highest dose; Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.	Drug: bleselumab; Intravenous (IV) infusion; Other Names: ASKP1240
Placebo Comparator: Placebo; Participants received a single 30-minute matching placebo infusion on Study Day 1, followed by a 90-day follow-up period.	Drug: Placebo; Intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic assessment through analysis of blood samples	Up to Day 90

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Kyowa Kirin Co., Ltd.
• Investigators: Study Director: Senior Medical Director, Astellas Pharma Global Development

Publications and helpful links

General Publications

• Vincenti F, Klintmalm G, Yang H, Ram Peddi V, Blahunka P, Conkle A, Santos V, Holman J. A randomized, phase 1b study of the pharmacokinetics, pharmacodynamics, safety, and tolerability of bleselumab, a fully human, anti-CD40 monoclonal antibody, in kidney transplantation. Am J Transplant. 2020 Jan;20(1):172-180. doi: 10.1111/ajt.15560. Epub 2019 Sep 9.

Helpful Links

• Link to results and other applicable study documents on the Astellas Clinical Trials website
• Link to plain language summary of the study on the Trial Results Summaries website

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2010
• Primary Completion (Actual): January 23, 2012
• Study Completion (Actual): January 23, 2012

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (Estimated): January 19, 2011

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Kidney Transplantation; Pharmacology; ASKP1240
• Additional Relevant MeSH Terms: bleselumab
• Other Study ID Numbers: 7163-CL-0103

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.
• IPD Sharing Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• IPD Sharing Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No