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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279538
• Other study ID #: 7163-CL-0103
• Status: Completed
• Phase: Phase 1
• Start date: November 17, 2010
• Est. completion date: January 23, 2012

Study information

• Verified date: December 2023
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 23, 2012
• Est. primary completion date: January 23, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• bleselumab
Intravenous (IV) infusion
• Placebo
Intravenous (IV) infusion

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center, The Transplant Institute	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Illinois Medical Center	Chicago	Illinois
United States	Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati - University Internal Medicine Associates	Cincinnati	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Central Pennsylvania Transplant Associates	Harrisburg	Pennsylvania
United States	The Methodist Hospital	Houston	Texas
United States	St. Barnabas Medical Center	Livingston	New Jersey
United States	University of Wisconsin	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Methodist University Hospital	Memphis	Tennessee
United States	Stanford University Medical Center	Palo Alto	California
United States	University of Utah Hospital	Salt Lake City	Utah
United States	California Institute of Renal Research	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	UCSF Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic assessment through analysis of blood samples		Up to Day 90

External Links

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