Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on T… (NCT04670926) | Clinical Trial Compass
UnknownNot Applicable
Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
United States75 participantsStarted 2021-06-03
Plain-language summary
This is an investigator-initiated, single-center, prospective, randomized, proof of concept study. In this study patients who are status post kidney transplantation and meet the inclusion and exclusion criteria will undergo immunosuppression reduction and will be followed closely to assess stability of graft function.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. All males or females of at least 18 years of age.
✓. Have the ability to understand the requirements of the study and are able to provide written informed consent.
✓. Recipient of a primary deceased-donor or living donor kidney transplant.
✓. Patients at low-immunological risk for acute rejection defined as cPRA of less than 50; no DSA; non-African American recipients
✓. HLA crossmatch negative (virtual cross match acceptable)
✓. Allograft from a deceased donor with KDPI \< 50%
Exclusion criteria
✕. Inability or unwillingness to provide informed consent.
✕. Need for combined organ transplantation with an extra-renal organ transplant.
✕. Recipients of previous non-renal solid organ and/or islet cell transplantation.
✕. Infection with HIV
✕. Patients with Hepatitis B or C PCR positive.
✕. Patients on corticosteroids at the time of transplantation
✕. Patients with leucopenia (WBC \<3.0) and thrombocytopenia (platelets \<100)