Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02474667
Eligibility Criteria:
Inclusion Criteria:
1. All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits.
2. Males and females ≥ 18 years of age.
3. Renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
4. Patient is to be the recipient of a first kidney transplant from a deceased donor.
5. Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
6. Body mass index \< 40 based on dry weight. Dry weight and height parameters obtained within 7 days prior to study entry may be used..
7. Estimated donor organ cold ischemia time less than 30 hours (for PMP kidneys less than 40 hours).
Exclusion Criteria
1. Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
2. Recipient of an ABO-incompatible kidney.
3. Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
4. Recipient of a kidney preserved by normothermic pulsatile machine perfusion.
5. Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
6. Currently participating in or has participated in an investigational drug or medical device study within 30 days or five drug half-lives, whichever is longer, prior to enrollment into this study. Patients cannot be given another investigational agent during the course of this study (through Day 360). Patients may participate in another concurrent study only if that study is a non-interventional, observational investigation.
7. Concurrent sepsis or active bacterial infection.
8. Has an active malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma in situ of the skin that has been adequately treated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02474667
Study Brief:
Protocol Section:
NCT02474667