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:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT00615966
Eligibility Criteria:
Inclusion Criteria:
* Scheduled to receive a kidney transplant from a deceased expanded criterion donor (ECD) or a donor cardiac death (DCD) donor that was exposed to no more than 36 hr of cold ischemia prior to transplantation, or scheduled to receive a kidney transplant from a standard criterion donor (SCD) that was exposed to 24-36 hr of cold ischemia prior to transplantation
* Willing to use adequate contraception for at least 4 weeks after dosing
* Willing and able to provide written Informed Consent and to comply with the requirements of the study
Exclusion Criteria:
* If female, subject is pregnant or lactating
* Known bleeding diathesis
* INR at Screening \> 1.5
* Platelet count at Screening below LLN and judged clinically significant
* Use of Plavix, anticoagulants other than aspirin, antithrombotics, and/or blood-thinning agents within 10 days prior to study entry
* Previous receipt of an organ transplant
* Will receive concurrent transplant of any additional organ(s)
* Clinically significant active infection at study entry
* Surgery within 2 weeks prior to study entry
* Believed to have used an illicit drug and/or abused alcohol within 3 months prior to study entry
* Presence of a psychiatric illness that might interfere with study participation
* Cancer, other than basal cell or squamous cell cancer of the skin, within 2 years prior to study entry
* Scheduled to receive a kidney transplant from a low risk donor
* Currently participation, or participated within 30 days prior to study entry, in an investigational drug study
* Known allergy to kanamycin
* History or presence of any medical condition or disease that could place the subject an unacceptable risk for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT00615966
Study Brief:
Protocol Section:
NCT00615966