Clinical Trials Logo

Clinical Trial Summary

Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.


Clinical Trial Description

The investigators will conduct a single-center, prospective, open-label, randomized study to evaluate the difference in neurocognitive side effects between Envarsus and immediate release tacrolimus. Eligible patients will be enrolled within 8 weeks post-transplantation. They will be administered a baseline panel of neurocognitive tests. They will then be randomized to either continue on immediate release tacrolimus or Envarsus. 6 weeks after randomization, the neurocognitive tests will be repeated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03461445
Study type Interventional
Source University of California, Davis
Contact
Status Completed
Phase Phase 4
Start date April 1, 2018
Completion date July 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT04369456 - Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients N/A
Recruiting NCT06001320 - De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Trans Recip Early Phase 1
Withdrawn NCT04560582 - Immunosuppression Reduction in Failed Allograft Guided by cfDNA
Not yet recruiting NCT05782543 - Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion N/A
Completed NCT03996551 - ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study N/A
Recruiting NCT05081141 - HHV8 and Solid Organ Transplantation
Recruiting NCT04508907 - A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients Phase 4
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Recruiting NCT04713774 - Bone Density and Vascular Calcifications Evolution After Renal Transplant
Active, not recruiting NCT05483725 - Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.
Recruiting NCT06095492 - Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus N/A
Active, not recruiting NCT04207177 - Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects Phase 4
Recruiting NCT03410654 - Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR. Early Phase 1
Completed NCT03373266 - Serun Fluoride and Kidney Transplant Phase 2
Completed NCT04835948 - Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
Not yet recruiting NCT04514666 - VOCs in Kidney and Liver Transplants N/A
Recruiting NCT03373500 - Effect of Dietary Salt Reduction on Blood Pressure in Kidney Transplant Recipients N/A
Recruiting NCT05900401 - Delayed Tolerance Through Mixed Chimerism Phase 1/Phase 2
Not yet recruiting NCT05166460 - Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation N/A
Recruiting NCT05977387 - Pediatric Kidney Transplant