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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01780844

Enrollment

149

Registered

2013-01-31

Start date

2013-03-05

Completion date

2017-01-27

Last updated

2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation, de novo Kidney Transplantation, ASKP1240

Brief 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).

Interventions

DRUGASKP1240

intravenous infusion

DRUGTacrolimus

intravenous or oral

DRUGMycophenolate Mofetil (MMF)

intravenous or oral

DRUGBasiliximab

intravenous

DRUGMethylprednisone

Intravenous

DRUGPrednisone

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is a recipient of a de novo kidney from a living or deceased donor

Exclusion criteria

* Subject has induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen * Subject has previously received or is receiving an organ transplant other than a kidney * Subject will receive a solitary kidney from a deceased donor \< 5 years of age * Subject will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours * Subject will receive a kidney that meets both Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. Note: a kidney that meets either ECD or DCD criteria is eligible for inclusion * Subject will receive an ABO incompatible donor kidney * Subject has a current calculated panel reactive antibody (cPRA) level \>50%

Design outcomes

Primary

Measure	Time frame
Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review	6 months

Secondary

Measure	Time frame	Description
Glomerular Filtration Rate (GFR)	6 months	GFR is based on Modification of Diet in Renal Disease (4 variable-MDRD) criteria
Patient Survival	6 months	Subject survival is defined as any subject who does not die during the study.
Graft Survival	6 months	Graft survival is defined as any subject who does not experience graft loss during the study. Graft loss is defined as subject death, retransplantation, transplant nephrectomy, or the permanent return to dialysis (greater than 30 days).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026