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

NCT01279538 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-17

No results posted yet for this study

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

DRUG

bleselumab

Intravenous (IV) infusion

DRUG

Placebo

Intravenous (IV) infusion

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    collaborator INDUSTRY

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Senior Medical Director · Astellas Pharma Global Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-17
Primary Completion
2012-01-23
Completion
2012-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01279538 on ClinicalTrials.gov