MedTrace Logo

A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

NCT01780844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2025-11-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids \[calcineurin inhibitor (CNI) avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids \[CNI minimization-MMF avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).

Conditions

  • Kidney Transplantation

Interventions

DRUG

ASKP1240

intravenous infusion

DRUG

Tacrolimus

intravenous or oral

DRUG

Mycophenolate Mofetil (MMF)

intravenous or oral

DRUG

Basiliximab

intravenous

DRUG

Methylprednisone

Intravenous

DRUG

Prednisone

Oral

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Senior Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-05
Primary Completion
2014-06-30
Completion
2017-01-27
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 NCT01780844 on ClinicalTrials.gov