Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
13 participants
INTERVENTIONAL
2020-03-02
2022-03-01
Brief Summary
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Detailed Description
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Group 1 - patients with high IPV (designated as ≥ 30%). Group 2 - patients with normal IPV (\< 30%). Will assess risk of subclinical acute rejection in patients with high IPV compared to normal IPV. All tacrolimus 12 h trough levels in patients with stable allograft function at least 3 months post-transplant.
Calculation of IPV: CV (%) = (SD/mean Tac trough concentration) x 100 (if stable total daily dose). To take into account dose changes, obtained levels will be corrected for the corresponding daily dose of tacrolimus to help correctly calculate IPV (CV C0/D-IPV) (6-7).
Patients will be tested with TruGraf one time during the study.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group 1 - Patients with high IPV (designated as ≥ 30%).
Patients with high IPV (designated as ≥ 30%).
TruGraf test
To obtain longitudinal TruGraf testing in patients with stable creatinine, high and normal IPV in tacrolimus levels, between 3 and 18 months post-transplant at the University of Maryland post-transplant clinic.
Group 2 - patients with normal IPV (< 30%).
Patients with normal IPV (\< 30%). Will assess risk of subclinical acute rejection in patients with high IPV compared to normal IPV. All tacrolimus 12 h trough levels in patients with stable allograft function at least 3 months post-transplant.
TruGraf test
To obtain longitudinal TruGraf testing in patients with stable creatinine, high and normal IPV in tacrolimus levels, between 3 and 18 months post-transplant at the University of Maryland post-transplant clinic.
Interventions
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TruGraf test
To obtain longitudinal TruGraf testing in patients with stable creatinine, high and normal IPV in tacrolimus levels, between 3 and 18 months post-transplant at the University of Maryland post-transplant clinic.
Eligibility Criteria
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Inclusion Criteria
2. Have the ability to understand the requirements of the study and are able to provide written informed consent.
3. Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
4. Stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels)
5. Kidney transplant patients who \>90 days (+/- 2 weeks) post-transplant will be included in this study
6. Patients with at least 3 tacrolimus trough levels( deemed as appropriately 12-hour trough levels) within 3-36 months post-transplant
Exclusion Criteria
2. Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
3. Recipients of previous non-renal solid organ and/or islet cell transplantation.
4. Infection with HIV.
5. Infection with BK nephropathy.
6. Patients that have nephrotic range proteinuria (urine protein \>3 gm/day).
18 Years
ALL
No
Sponsors
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Transplant Genomics, Inc.
INDUSTRY
University of Maryland, Baltimore
OTHER
Responsible Party
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Roberto Kalil
Professor
Locations
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University of Maryland Medical Center
Baltimore, Maryland, United States
Countries
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Other Identifiers
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HP-00089343
Identifier Type: -
Identifier Source: org_study_id