Status:
TERMINATED
TruGraf Utilization in High IPV Levels
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Transplant Genomics, Inc.
Conditions:
Kidney Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Intra-patient variability (IPV) in tacrolimus is associated with premature graft loss. The rate of acute rejection episodes is higher in these patients, and acute rejection impacts negatively on graft...
Detailed Description
Study Population: Kidney transplant recipients with stable renal function with regular follow-up at the University of Maryland post-transplant clinic with at least 3 levels deemed as appropriately 12-...
Eligibility Criteria
Inclusion
- Patients who meet all of the following criteria are eligible for enrollment:
- Are 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 or subsequent deceased-donor or living donor kidney transplantation.
- Stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels)
- Kidney transplant patients who \>90 days (+/- 2 weeks) post-transplant will be included in this study
- Patients with at least 3 tacrolimus trough levels( deemed as appropriately 12-hour trough levels) within 3-36 months post-transplant
Exclusion
- Patients who meet any of these criteria are not eligible for enrollment:
- Inability or unwillingness to provide informed consent.
- Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HIV.
- Infection with BK nephropathy.
- Patients that have nephrotic range proteinuria (urine protein \>3 gm/day).
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04280276
Start Date
March 2 2020
End Date
March 1 2022
Last Update
December 16 2024
Active Locations (1)
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1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201