Clinical Trial Details
| Trial ID: | L0351 |
| Source ID: | NCT04917718 |
| Associated Drug: | Conversion From Ir Tacrolimus To Xr Tacrolimus |
| Title: | Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Diseases|Heart Transplant |
| Interventions: | DRUG: Conversion from IR Tacrolimus to XR Tacrolimus |
| Outcome Measures: | Primary: Urinary neutrophil gelatinase-associated lipocalin (NGAL), Change in Urinary NGAL level (ng/mL), 4 weeks | Secondary: Estimated Glomerular Filtration Rate (eGFR), Change in eGRF level by the Creatinine-Cystatin C CKD-EPI equation (mL/min/1.73m2), 4 weeks|Microalbuminuria, Change in Urine albumin-creatinine ratio, 4 weeks|CYP3A5 expressor category, CYP3A5 genotyping to determine expressor category, Baseline|Heart transplant rejection, The rate of rejection as defined as treated rejection within the last 30 days for any grade\>1R, AMR, or acute graft dysfunction (LVEF drop greater than 10%), 1 year|Cardiac allograft vasculopathy, The rate of cardiac allograft vasculopathy based on coronary angiography with or without IVUS and right heart catheterization hemodynamics, 1 year|Blood pressure, Change in blood pressure (mmHg), 1 year|Serum glucose, Change in serum glucose levels (mg/dL), 1 year|LDL Cholesterol, Change in LDL cholesterol level (mg/dL), 1 year |
| Sponsor/Collaborators: | Sponsor: Loyola University | Collaborators: Veloxis Pharmaceuticals |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 42 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER |
| Start Date: | 2021-08-16 |
| Completion Date: | 2024-12-31 |
| Results First Posted: | |
| Last Update Posted: | 2022-04-13 |
| Locations: | Loyola University Medical Center, Maywood, Illinois, 60153, United States |
| URL: | https://clinicaltrials.gov/show/NCT04917718 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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