Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Opsona Therapeutics Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function
