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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT00906204
Eligibility Criteria:
Inclusion Criteria:
* Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation
* Male or female subject who has reached legal age in the state where they reside and is at least 18 years of age
* Deceased or living donors
* Compatible ABO blood type
* Expanded-criteria donor (ECD) kidneys with a donor grade score of ≤ 25 (as developed by Nyberg, et al.)
* If Kidneys are pumped, they must meet the following pumping parameters: resistance \<0.35 with a flow rate of \>60 ml/min.
Exclusion Criteria:
* Recipient age \>65 years
* PRA \>50%, or donor-specific antibody
* CIT \>30 hours
* Re-transplant patients
* Multi-organ transplant recipients (example: kidney/pancreas or kidney/liver)
* Renal transplant recipients planned for future pancreas transplantation
* Current unstable cardiovascular disease or history of myocardial infarction within the previous 6 months
* Current malignancy or history or malignancy (within the previous 5 years) with the exception of non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.
* Hepatitis B and C recipients or active liver disease
* HIV positive recipients
* Primary disease requiring treatment with steroids after transplantation
* Expanded-criteria donor kidneys (current UNOS criteria) with a donor grade score of \> 25
* Donation after cardiac death (DCD) donors
* Dual adult kidneys
* Recipients of pediatric (age \<12 years) unilateral or en-bloc kidneys
* Previous treatment with rATG
* Known hypersensitivity, extensive exposure, or allergy to rabbits
* Pregnant
* Any condition that in the investigator's opinion may compromise study participation (e.g., history or likelihood of non-compliance with immunosuppression regimen, protocol visits, tests, and studies)
Relative Exclusion Criteria:
* Patients with a BMI \> 37 should be considered on an individual basis based on overall health and body habitus.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00906204
Study Brief:
Protocol Section:
NCT00906204