Status:
COMPLETED
Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function
Lead Sponsor:
Opsona Therapeutics Ltd.
Conditions:
Delayed Graft Function
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 transp...
Eligibility Criteria
Inclusion
- Inclusion criteria
- INCLUSION CRITERIA FOR TRANSPLANT RECIPIENTS
- 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
- INCLUSION CRITERIA FOR DONOR KIDNEY:
- 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
- EXCLUSION CRITERIA FOR TRANSPLANT RECIPIENTS:
- 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
- EXCLUSION CRITERIA FOR ALL DONOR KIDNEYS
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2016
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01794663
Start Date
October 1 2012
End Date
June 30 2016
Last Update
February 16 2017
Active Locations (50)
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1
Research Site
Los Angeles, California, United States, 90033
2
Research Site
Washington D.C., District of Columbia, United States, 20007
3
Research Site
Tampa, Florida, United States, 33606
4
Research Site
Chicago, Illinois, United States, 60612