NCT01442337

A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients

A Phase 2/3, Double-Blind, Placebo-Controlled, Two-Part Study (Part 1 Open-Label) to Assess the Safety, Efficacy and Pharmacokinetics of Single Intravenous Doses of ASP8597 (Diannexin) in de Novo Kidney Transplant Recipients

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.

Detailed description

This is a two-part study. Part 1 (Phase 2) has completed enrollment. Subjects are currently being followed per protocol. Data from Part 1 will be used to determine the doses used in Part 2 (Phase 3). Part 2 will enroll approximately 573 subjects and is planned to have 2 doses of ASP8597 (low dose and either the high or highest dose) along with placebo.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	ASP8597	one time IV dose
DRUG	Placebo	one time IV dose

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-09-28
• Last updated: 2014-06-20

Locations

19 sites across 1 country: United States