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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01279538
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : February 10, 2012
Kyowa Hakko Kirin Co., Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: ASKP1240 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ASKP1240 lowest dose Drug: ASKP1240
Intravenous (IV) infusion

Experimental: ASKP1240 low dose Drug: ASKP1240
Intravenous (IV) infusion

Experimental: ASKP1240 high dose Drug: ASKP1240
Intravenous (IV) infusion

Experimental: ASKP1240 highest dose Drug: ASKP1240
Intravenous (IV) infusion

Placebo Comparator: Placebo Drug: Placebo
Intravenous (IV) infusion

Primary Outcome Measures :
  1. Pharmacokinetic assessment through analysis of blood samples [ Time Frame: Up to Day 90 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01279538

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

Responsible Party: Astellas Pharma Inc Identifier: NCT01279538     History of Changes
Other Study ID Numbers: 7163-CL-0103
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation