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

Study 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.

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

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: bleselumab
* Drug: Placebo


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASKP1240 lowest dose<br>Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. | Drug: bleselumab<br>* Intravenous (IV) infusion<br>* Other names: ASKP1240;|
| Experimental: ASKP1240 low dose<br>Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. | Drug: bleselumab<br>* Intravenous (IV) infusion<br>* Other names: ASKP1240;|
| Experimental: ASKP1240 high dose<br>Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. | Drug: bleselumab<br>* Intravenous (IV) infusion<br>* Other names: ASKP1240;|
| Experimental: ASKP1240 highest dose<br>Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. | Drug: bleselumab<br>* Intravenous (IV) infusion<br>* Other names: ASKP1240;|
| Placebo Comparator: Placebo<br>Participants received a single 30-minute matching placebo infusion on Study Day 1, followed by a 90-day follow-up period. | Drug: Placebo<br>* Intravenous (IV) infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic assessment through analysis of blood samples |  | Up to Day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacology, Pharmacokinetics, ASKP1240, Kidney Transplantation