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 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT01680861
Eligibility Criteria:
Inclusion Criteria:
* Weight \> 40 kg.
* Deceased donor (SCD) or LD.
* Donor-recipient 1 haplotype matched pairs with a minimum matching of 1 HLA DR antigen.
* Negative standard cross match for T cells.
* Pretransplant panel reactive antibodies of \< 30%.
* Graft required to be functional, producing at least 100ml of urine within 24hr after transplantation.
Exclusion Criteria:
* Previously received or is receiving an organ transplant other than a kidney.
* Donor organ with a cold ischemic time \> 48 hours.
* ABO incompatible donor kidney.
* Recipients of T cell, or B cell crossmatch positive transplant.
* Panel reactive antibody (PRA) \>30%
* HIV or Hepatitis C virus, or Hepatitis B virus antigenemia.
* Current malignancy or a history of malignancy
* Liver disease
* Uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer
* Use of warfarin, fluvastatin, or herbal supplements during the study.
* Use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
* Hypersensitivity to thymoglobulin, IL-2 receptor inhibitor monoclonal antibodies, tacrolimus, everolimus, MPA, or corticosteroids.
* Pregnant or lactating.
* Abnormal screening/baseline labs WBC, platelet count, triglycerides, and cholesterol Double kidneys,ECD, pediatric en-block, and donation after cardiac death (DCD)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01680861
Study Brief:
Protocol Section:
NCT01680861