NCT01279538

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	bleselumab	Intravenous (IV) infusion
DRUG	Placebo	Intravenous (IV) infusion

Timeline

• Start date: 2010-11-17
• Primary completion: 2012-01-23
• Completion: 2012-01-23
• First posted: 2011-01-19
• Last updated: 2025-11-17

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study