Clinical trial NCT01780844: A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation
de novo Kidney Transplantation
ASKP1240
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin Co., Ltd.
First posted: 2013-01-31
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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%

Primary outcomes:
measure: Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review
timeFrame: 6 months
Secondary outcomes:
measure: Glomerular Filtration Rate (GFR)
timeFrame: 6 months
measure: Patient Survival
timeFrame: 6 months
measure: Graft Survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site US10006
state: Alabama
city: Phoenix
country: United States
facility: Site US10024
state: Arizona
city: Los Angeles
country: United States
facility: Site US10008
state: California
city: Palo Alto
country: United States
facility: Site US10021
state: California
city: San Diego
country: United States
facility: Site US10030
state: California
city: San Francisco
country: United States
facility: Site US10004
state: California
city: San Francisco
country: United States
facility: Site US10003
state: California
city: Aurora
country: United States
facility: Site US10013
state: Colorado
city: Atlanta
country: United States
facility: Site US10007
state: Georgia
city: Augusta
country: United States
facility: Site US10041
state: Georgia
city: Chicago
country: United States
facility: Site US10010
state: Illinois
city: Chicago
country: United States
facility: Site US10018
state: Illinois
city: Chicago
country: United States
facility: Site US10037
state: Illinois
city: Lexington
country: United States
facility: Site US10015
state: Kentucky
city: New Orleans
country: United States
facility: Site US10045
state: Louisiana
city: Baltimore
country: United States
facility: Site US10014
state: Maryland
city: Ann Arbor
country: United States
facility: Site US10017
state: Michigan
city: Saint Louis
country: United States
facility: Site US10025
state: Missouri
city: Livingston
country: United States
facility: Site US10022
state: New Jersey
city: Bronx
country: United States
facility: Site US10019
state: New York
city: Buffalo
country: United States
facility: Site US10031
state: New York
city: New York
country: United States
facility: Site US10034
state: New York
city: New York
country: United States
facility: Site US10023
state: New York
city: Chapel Hill
country: United States
facility: Site US10036
state: North Carolina
city: Charlotte
country: United States
facility: Site US10042
state: North Carolina
city: Durham
country: United States
facility: Site US10016
state: North Carolina
city: Greenville
country: United States
facility: Site US10026
state: North Carolina
city: Cincinnati
country: United States
facility: Site US10009
state: Ohio
city: Cleveland
country: United States
facility: Site US10040
state: Ohio
city: Cleveland
country: United States
facility: Site US10032
state: Ohio
city: Harrisburg
country: United States
facility: Site US10027
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site US10038
state: Pennsylvania
city: Charleston
country: United States
facility: Site US10012
state: South Carolina
city: Memphis
country: United States
facility: Site US10028
state: Tennessee
city: Nashville
country: United States
facility: Site US10035
state: Tennessee
city: Dallas
country: United States
facility: Site US10001
state: Texas
city: Fort Worth
country: United States
facility: Site US10002
state: Texas
city: Houston
country: United States
facility: Site US10029
state: Texas
city: Houston
country: United States
facility: Site US10044
state: Texas
city: Salt Lake City
country: United States
facility: Site US10033
state: Utah
city: Charlottesville
country: United States
facility: Site US10020
state: Virginia
city: Madison
country: United States
facility: Site US10005
state: Wisconsin
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Senior Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.