NCT01780844

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Subjects will be followed for 6 months. Upon completion of the first 6 months of the study, subjects may participate in the Long Term Extension period of the study. Subjects will remain on their original treatment arm up to three years post-transplant (and / or Sponsor discontinues development or the subject no longer wishes to participate in the study).

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-03-05
• Primary completion: 2014-06-30
• Completion: 2017-01-27
• First posted: 2013-01-31
• Last updated: 2025-11-21

Locations

42 sites across 1 country: United States

Regulatory

• FDA-regulated drug study