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

Study:

A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

Rationale:

n/a

Purpose:

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).

Study Status: Recruiting

Recruiting:
n/a

Condition Intervention Phase
Kidney Transplantation Drug: ASKP1240
Drug: Tacrolimus
Drug: Mycophenolate Mofetil (MMF)
Drug: Basiliximab
Drug: Corticosteroids
Phase 2

Verified by Astellas Pharma Global Development, Inc. January, 2014

Sponsored by: Astellas Pharma Global Development, Inc.
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov identifier: NCT01780844

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Senior Medical Director., Study Director

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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