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
1 other identifier
interventional
50
1 country
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2010
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2010
CompletedFirst Submitted
Initial submission to the registry
January 18, 2011
CompletedFirst Posted
Study publicly available on registry
January 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2012
CompletedNovember 17, 2025
November 1, 2025
1.2 years
January 18, 2011
November 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic assessment through analysis of blood samples
Up to Day 90
Study Arms (5)
ASKP1240 lowest dose
EXPERIMENTALParticipants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.
ASKP1240 low dose
EXPERIMENTALParticipants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.
ASKP1240 high dose
EXPERIMENTALParticipants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.
ASKP1240 highest dose
EXPERIMENTALParticipants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.
Placebo
PLACEBO COMPARATORParticipants received a single 30-minute matching placebo infusion on Study Day 1, followed by a 90-day follow-up period.
Interventions
Intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Kyowa Kirin Co., Ltd.collaborator
Study Sites (21)
Stanford University Medical Center
Palo Alto, California, 94304, United States
California Institute of Renal Research
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
UCSF Medical Center
San Francisco, California, 94143, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Beth Israel Deaconess Medical Center, The Transplant Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinnati - University Internal Medicine Associates
Cincinnati, Ohio, 45219, United States
Central Pennsylvania Transplant Associates
Harrisburg, Pennsylvania, 17104, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
The Methodist Hospital
Houston, Texas, 77030, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Related Publications (1)
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.
PMID: 31397943DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2011
First Posted
January 19, 2011
Study Start
November 17, 2010
Primary Completion
January 23, 2012
Study Completion
January 23, 2012
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
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.