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Clinical Trial Details

Trial ID: L1577
Source ID: NCT04665310
Associated Drug: Envarsus Xr
Title: Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans with Kidney Transplant
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Kidney Disease, End-Stage|Donor Specific Antibodies|Acute Rejection of Renal Transplant
Interventions: DRUG: Envarsus XR
Outcome Measures: Primary: Number of participants reaching the composite endpoint, Composite endpoint of freedom from all of the following: i) biopsy-proven T-cell mediated rejection Banff Grade ≥1A, ii) antibody-mediated rejection, iii) de novo DSA, or iv) immune-mediated graft loss. The endpoint is a binary endpoint (Yes or No) of the composite of all 4 potential outcomes. The presence of any one of the four possible outcomes will be counted as a No for the binary endpoint (no freedom from the composite endpoint). The absence of all 4 possible outcomes will be counted as Yes for freedom from all of the possible outcomes., 6 months | Secondary: Proportion of subjects experiencing nephrotoxicity during the study, Increase in serum creatinine of ≥0.3mg/dL, 6 months|Proportion of subjects experiencing neurotoxicity during the study, Clinical intolerability including headache or significant tremors that resolve with reduction of the dose of Envarsus, 6 months|Proportion of subjects experiencing infectious complications during the study, Participants requiring extended (\>2 weeks) reduction in dose of Envarsus due to BK-polyomavirus or cytomegalovirus viral loads at 1, 3, and 6 months post-transplant, 6 months|Difference in estimated glomerular filtration rate at 1, 3, and 6 months between groups of enrolled subjects, Assessed as the Chronic Kidney Disease - Epidemiology Collaboration equation, 6 months|Difference in immunosuppressant side effects between enrolled subjects, Assessed using the "Immunosuppressant Side Effects Instrument - The Memphis Survey" questionnaire, 6 months|Enrolled subject overall survival and Graft survival at 6 months, Freedom from death and from graft loss at 6 months, 6 months
Sponsor/Collaborators: Sponsor: The Methodist Hospital Research Institute | Collaborators: Veloxis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 46
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-09-01
Completion Date: 2025-10-31
Results First Posted:
Last Update Posted: 2025-03-14
Locations:
URL: https://clinicaltrials.gov/show/NCT04665310