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

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).

Timeline

Start

2013-03-05

Primary completion

2014-06-30

Completion

2017-01-27

Outcome

Mixed primary results

paper For the primary endpoint (incidence of biopsy-proven acute rejection [BPAR] at 6 months), bleselumab + IR-TAC was noninferior to SoC PMID 31509331 ↗

paper bleselumab + MMF did not demonstrate noninferiority to SoC (difference 30.7%; 95% CI 15.2%-46.2%). PMID 31509331 ↗

Publications

• Harland RC, Klintmalm G, Jensik S, Yang H, Bromberg J, Holman J, Kumar MSA, Santos V, Larson TJ, Wang X. Efficacy and safety of bleselumab in kidney transplant recipients: A phase 2, randomized, open-label, noninferiority study. Am J Transplant. 2020 Jan;20(1):159-171. doi: 10.1111/ajt.15591. Epub 2019 Oct 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Mofetil	Small molecule	1 g	Intravenous
Subject	Tacrolimus	Small molecule	0.1 mg/kg	Intravenous
Subject	bleselumab	Monoclonal antibody	200 mg	Intravenous
Background	Basiliximab	Monoclonal antibody	20 mg	Intravenous
Background	Methylprednisone	Unknown	—	Intravenous
Background	Prednisone	Other / unclassified	—	Oral

Indications

No indication recorded.