NCT01567085

Brief Summary

Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_2

Geographic Reach
6 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

August 29, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 3, 2019

Completed
Last Updated

May 3, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

March 27, 2012

Results QC Date

May 25, 2018

Last Update Submit

January 30, 2019

Conditions

Stage V Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation

    Results are reported for post-transplantation treatment failure and composite endpoints, defined as the occurrence of biopsy-proven acute antibody-mediated rejection (AMR), graft loss, death, or loss to follow-up (including discontinuation) in the first 9 weeks post transplantation. The diagnosis of acute AMR (occurring within the first 9 weeks post transplantation) was based on kidney allograft dysfunction and a biopsy performed due to suspected rejection, proteinuria, increased serum creatinine, or acute tubular necrosis. Treatment failure was the occurrence of at least 1 of the composite endpoint components by Week 9 post transplantation. A participant experiencing multiple events was only counted once for the composite endpoint.

    Baseline, Week 9

Other Outcomes (2)

  • Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12

    Baseline, Month 12

  • Participants That Developed Severe ACR (Other AE Of Interest) At Month 12

    Baseline, Month 12

Study Arms (1)

Eculizumab

EXPERIMENTAL

Eculizumab 1200 milligrams (mg) was administered intravenously (IV) over 25 to 45 minutes 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.

Drug: Eculizumab

Interventions

EculizumabDRUG
Also known as: Soliris
Eculizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participants ≥18 years old.
  • Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.
  • History of prior exposure to HLA (human leukocyte antigen):
  • Prior solid organ or tissue allograft
  • Pregnancy
  • Blood transfusion
  • Prior exposure to specific donor's HLA

You may not qualify if:

  • Has received treatment with eculizumab at any time prior to enrolling in this study.
  • Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
  • History of severe cardiac disease.
  • Prior splenectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Adelaide, 5000, Australia

Location

Unknown Facility

Camperdown, 2050, Australia

Location

Unknown Facility

Parkville, 3050, Australia

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Paris, 75010, France

Location

Unknown Facility

Paris, 75743, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Tours, 37044, France

Location

Unknown Facility

Brescia, 25123, Italy

Location

Unknown Facility

Padua, 35128, Italy

Location

Unknown Facility

Barcelona, 08907, Spain

Location

Unknown Facility

Gothenburg, 413 45, Sweden

Location

Unknown Facility

Uppsala, 751 85, Sweden

Location

Unknown Facility

Cambridge, CB2 2QQ, United Kingdom

Location

Unknown Facility

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Interventions

eculizumab

Results Point of Contact

Title
Alexion Pharmaceuticals, Inc. (Sponsor)
Organization
Alexion Pharmaceuticals, Inc.
clinicaltrials@alexion.com

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 30, 2012

Study Start

August 29, 2012

Primary Completion

June 11, 2015

Study Completion

May 24, 2017

Last Updated

May 3, 2019

Results First Posted

May 3, 2019

Record last verified: 2019-01

Locations

GB(2)ES(1)IT(2)AU(3)SE(2)FR(5)