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Clinical Trial Details

Trial ID: L1165
Source ID: NCT03289650
Associated Drug: Tacrolimus
Title: Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03289650/results
Conditions: End Stage Renal Disease|Rejection of Renal Transplant
Interventions: DRUG: Tacrolimus|DRUG: Tacrolimus Extended Release Oral Tablet [Envarsus]
Outcome Measures: Primary: Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant, change in the mean eGFR from the baseline (2 weeks post transplant), 3 months (post transplant) , and 12 months (post transplant)., 2 weeks post transplant through 12 months post transplant | Secondary: Change in Subpopulations of T Cells From 2 Weeks Post Transplant Through 12 Months Post Transplant, Blood, urine and kidney tissue analysis via serial flow cytometric immunophenotyping (includes regulatory T and B cell populations as well as immune functions)., Measured at 2 weeks post transplant, 3 months post transplant, 12 months post transplant|Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant, Acute rejection of kidney transplant is determined via biopsy., Measured at 3 months post transplant, 12 months post transplant|Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant, Graft loss is determined via biopsy., Measured at 3 months post transplant, 12 months post transplant|Number of Subjects Deceased at at 3 Months and 12 Months Post-Transplant, Subject survival status is continually monitored via routine follow-up visits., Through 12 months post transplant|Number of Participants With Change in Allograft Immunohistopathology Profile, Tissue analysis via immunohistopathological staining and microscopic examination Moderate acute tubular necrosis =\> presence of focal coagulative necrosis or infarction on histopathologic examination Arteriolar hyalinosis grade 2 means: Replacement of degenerated smooth muscle cells by hyaline deposits in more than 1 arteriole, without circumferential involvement Global glomerulosclerosis \>grade 2, means glomerulosclerosis affecting more than 50% of glomeruli in the biopsy sample IFTA : Interstitial fibrosis and tubular atrophy: Inflammation in 26% to 50% of scarred cortical parenchyma, Measured at 3 months post transplant, 12 months post transplant
Sponsor/Collaborators: Sponsor: Lorenzo Gallon
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 29
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-09-05
Completion Date: 2021-02-23
Results First Posted: 2023-04-10
Last Update Posted: 2023-04-10
Locations: Northwestern University, Chicago, Illinois, 60611, United States
URL: https://clinicaltrials.gov/show/NCT03289650