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

Astellas Pharma Inc21 sites in 1 country50 target enrollmentNovember 17, 2010

ConditionsKidney Transplantation

Interventionsbleselumab Placebo

Drugsbleselumab Placebo

Overview

Phase: Phase 1
Intervention: bleselumab
Conditions: Kidney Transplantation
Sponsor: Astellas Pharma Inc
Enrollment: 50
Locations: 21
Primary Endpoint: Pharmacokinetic assessment through analysis of blood samples
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 17, 2010

End Date

January 23, 2012

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Responsible Party

Sponsor

Eligibility 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