Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function
A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanised Monoclonal Antibody That Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    opn-305 ...
  • Study Participants

When a patient receives a kidney transplant particularly if the kidney is from an older donor or one who has had the kidney removed after their heart has stopped, there is a risk that the newly transplanted kidney may not function immediately. If the delay in function means that dialysis is needed in the first 7 days after the transplantation then this is known as delayed graft function or dDGF. Also delayed graft function that does not require dialysis but is present because the serum creatinine does not fall sufficiently is known as functional delayed graft function or fDGF. This problem is often due to an excessive inflammatory reaction to not having had a blood supply between the time of donation and transplant.

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.
Study Started
Oct 31
Primary Completion
Jun 30
Study Completion
Jun 30
Last Update
Feb 16

Drug OPN-305

Intravenous infusion for 1 hour at start of transplant procedure

Drug Placebo

Intravenous infusion for 1 hour at start of transplant procedure

OPN-305 Experimental

Matching placebo Placebo Comparator


Inclusion criteria


First or second renal transplant recipient - for second renal transplantations;

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


Use of an investigational drug in the 30 days before Study Day 1
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
No Results Posted