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

This study has been completed.
Sponsor:
Collaborator:
Kyowa Hakko Kirin Company, Limited
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01279538
First received: January 18, 2011
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Kidney Transplantation
Drug: ASKP1240
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetic assessment through analysis of blood samples [ Time Frame: Up to Day 90 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: November 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279538

Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
California Institute of Renal Research
San Diego, California, United States, 92123
UCSF Medical Center
San Francisco, California, United States, 94143
California Pacific Medical Center
San Francisco, California, United States, 94115
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
University of Cincinnati - University Internal Medicine Associates
Cincinnati, Ohio, United States, 45219
Christ Hospital
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 Company, Limited
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01279538     History of Changes
Other Study ID Numbers: 7163-CL-0103
Study First Received: January 18, 2011
Last Updated: February 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Pharmacokinetics
Pharmacology
ASKP1240

ClinicalTrials.gov processed this record on September 22, 2014