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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT02314312
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years
* Recipients of first DDKT from ECD or AKI donors
* Patient willing to participate in the study
Exclusion Criteria:
* Multi-organ recipients
* Organ donation after Cardiac Death (DCD).
* PRA \> 20 % or with historical peak PRA \> 50%
* Patients who lost first graft due to immunological reason within the first year post-transplantation.
* ABO incompatible transplants or positive cross-match
* Patients with chronic inflammatory bowel disease.
* Severe allergy requiring acute treatment, or any known hypersensitivity to everolimus, thymoglobulin
* Thrombocytopenia (platelet \< 75,000/mm3), ANC \< 1,500 /mm3 or leucopenia (leucocytes \< 2,500/mm3), or Hb \< 6 g/dL
* Chronic active HCV, HIV, or HBsAg positive
* History of malignancy during the last five years, except squamous or basal cell carcinoma of the skin.
* Ongoing infection requiring treatment with a systemic antibiotic.
* Patient with severe hypercholesterolemia (\> 300 mg/dL) or hypertriglyceridemia (\> 600 mg/dL) that cannot be controlled
* Evidence of severe liver disease.
* Severe restrictive or obstructive pulmonary disorders.
* Pregnant or nursing (lactating) women.
* Patient who refuse to participate into the study or would like to withdraw from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02314312
Study Brief:
Protocol Section:
NCT02314312