Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function
NCT ID: NCT01794663
Last Updated: 2017-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
252 participants
INTERVENTIONAL
2012-10-31
2016-06-30
Brief Summary
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OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be partly responsible for increasing the risk of this inflammation. It is hoped that the effects of the inflammation will be reduced and therefore prevent dDGF and fDGF from occurring.
The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF as well as improving other measures of kidney function and the overall safety of the antibody. In the first part of the study, each patient received an Infusion of one of three possible doses of OPN-305 or a placebo and in the second part the most suitable dose of OPN-305 and a placebo would be used. The purpose of this second part of the study is to find out if a dose of OPN-305 which has already been tested in an earlier part of this study can prevent kidney graft dysfunction. For the purposes of this study, kidney function will be assessed using the composite of delayed graft function (dDGF) because dialysis is necessary in the first 7 days and functional delayed graft function that does not require dialysis but is present because the serum creatinine, a key measure of renal function, does not fall sufficiently (fDGF) in the first 7 days post-transplant.
Protocol OPN305-103 follows out to 12 months post-transplant the clinical status and graft function of patients who have completed the 6-month post-transplant period under Part A or Part B of OPN305-102.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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OPN-305
OPN-305
Intravenous infusion for 1 hour at start of transplant procedure
Matching placebo
Placebo
Intravenous infusion for 1 hour at start of transplant procedure
Interventions
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OPN-305
Intravenous infusion for 1 hour at start of transplant procedure
Placebo
Intravenous infusion for 1 hour at start of transplant procedure
Eligibility Criteria
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Inclusion Criteria
* The second transplant should NOT be due to rejection
* Panel Reactive Antibody (PRA) should be \<10%
* Minimum 3 months since the loss of the first transplanted kidney
* Dialysis-dependent at the time of transplantation as documented by:
* Requirement for at least 2 dialysis sessions/week in the 56 days before transplantation
* The donor kidney must be considered compatible according to local transplant guidelines
* An ECD donor defined as:
o Extended Criteria Donor defined as:
* Donor ≥60 years of age
* Donor 50-59 years of age with two of three of the following criteria present:
* Death due to cerebrovascular accident
* Pre-existing history of systemic hypertension
* Terminal creatinine \> 1.5mg/dL (132.6 µmol/L)
* Kidney allograft maintained in cold storage with or without machine perfusion
Exclusion Criteria
* Participation in any other research
* Known hypersensitivity to human monoclonal antibodies or any of the study-drug excipients
* Previous hypersensitivity to basiliximab or anti-thymocyte globulin (ATG)
* History or known HIV, HBV, or HCV-positive
* History of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin or cervical intraepithelial neoplasia
* Scheduled to undergo multi-organ transplantation
* Planned dual kidney transplantation
* Presence of clinically significant infections requiring continued therapy
* Active tuberculosis
* Existence of any surgical or medical condition, other than the current transplantation which, in the opinion of the investigator, might significantly alter the distribution, metabolism or excretion of study medication
* Presence of uncontrolled diabetes mellitus.
* Current drug and/or alcohol abuse
* History or presence of a medical condition or disease that in the investigator's assessment would place the patient at an unacceptable risk for study participation
* Lactating or pregnant woman
* Patient institutionalized by administrative or court order
* DCD or SCD donor kidney
* Terminal creatinine \>3mg/dL
* Donor who is known to have received an investigational drug for I-R injury or graft rejection (immunosuppressant) in the 48h before organ recovery
* Participation in any other research (drug or non-drug)
* Kidney donor \<5 years of age or \<20kg body weight
* Living donor allograft
* HLA or ABO incompatible kidney as defined by a negative cytotoxic crossmatch
* Donor institutionalized by administrative or court order
18 Years
ALL
No
Sponsors
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Opsona Therapeutics Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert M Miller, FRCS MBBS
Role: STUDY_DIRECTOR
OpsonaTherapeutics Ltd.
Locations
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Research Site
Los Angeles, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Tampa, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
New Orleans, Louisiana, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Livingston, New Jersey, United States
Research Site
New York, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Harrisburg, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Dallas, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Richmond, Virginia, United States
Research Site
Linz, , Austria
Research Site
Brussels, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Prague, , Czechia
Research Site
Bordeaux, , France
Research Site
Paris, , France
Research Site
Toulouse, , France
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Bochum, , Germany
Research Site
Bonn, , Germany
Research Site
Cologne, , Germany
Research Site
Erlangen, , Germany
Research Site
Heidelberg, , Germany
Research Site
Mannheim, , Germany
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Münster, , Germany
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Tübingen, , Germany
Research Site
Groningen, , Netherlands
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Leiden, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Bydgoszcz, , Poland
Research Site
Lodz, , Poland
Research Site
Szczecin, , Poland
Research Site
Warsaw, , Poland
Research Site
Warsaw, , Poland
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Santander, , Spain
Research Site
Zurich, , Switzerland
Research Site
London, , United Kingdom
Research Site
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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2012-001455-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OPN305-102
Identifier Type: -
Identifier Source: org_study_id
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