A Phase 4 interventional study of Envarsus and IR Tacrolimus in Kidney Transplant; Complications, Toxicity and Drug Toxicity, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by University of California, Davis · Phase 4, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 140 studies in Drug-Related Side Effects and Adverse Reactions with a site in United States — 13 open to participants now, 18 under way, 2 of them phase 3. Drug-Related Side Effects and Adverse Reactions · United States.
Among the 140 studies in Drug-Related Side Effects and Adverse Reactions with a site in United States, this one is the 51st largest by enrollment of the 95 interventional ones that give a count, is one of 6 that started in 2018, is one of 11 in phase 4, and was the 92nd registered.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
Browse Drug-Related Side Effects and Adverse Reactions studies →13 of the 140 studies in Drug-Related Side Effects and Adverse Reactions with a site in United States are open now. Recruiting first, the newest first:
Texas A&M University · Sites in United States
Ages 18–100
Florida Atlantic University · Sites in United States
Ages 65–110
Eli Lilly and Company · Sites in United States, Australia, China and 7 more countries
Ages 18+
Texas A&M University · Sites in United States
Ages 18+
Brigham and Women's Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 55 Drug-Related Side Effects and Adverse Reactions studies recruiting now, 37 (67%) set no upper age limit and 15 (27%) stop at 75 or younger; 14 take children under 18; 4 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
140 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 27 · Phase 3 14 · Phase 4 11
First in 1993; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 64 is below the median of 108 across 262 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.
Median enrollment 96 across the 95 interventional studies, 200 across the 35 observational. Of the 102 that completed or were terminated, 26 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 140 have an industry lead sponsor. The 10 most frequent:
University of California, Davis is the lead sponsor of 810 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
University of California, Davis has 1 study filed under Drug-Related Side Effects and Adverse Reactions — fewer than ten, so there is no comparison to draw.
6 of the studies in Drug-Related Side Effects and Adverse Reactions with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05358535Phase 3University of Texas Southwestern Medical CenterPropofol and Etomidate Admixtures Comparisons Trial (PEAC Trial) | 2027-01 |
| NCT05084196Phase 3Rutgers, The State University of New JerseyMelatonin for Prevention of Kidney Injury | 2027-06-01 |
| NCT06219720Texas A&M UniversityThe Texas Interprofessional Pharmacogenomics (IPGx) | 2026-11 |
| NCT07169851Eli Lilly and CompanyA Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer | 2026-12 |
| NCT05838638University of Central FloridaSerious Gaming for Chemotherapy-induced Nausea and Vomiting | 2027-06-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 140 studies in Drug-Related Side Effects and Adverse Reactions with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive immediate release tacrolimus
Drug: IR Tacrolimus
Patients will be converted to Envarsus formulation of tacrolimus
Drug: Envarsus
Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
Change in Neurocognitive Side Effects
Change in MOCA (Montreal Cognitive Assessment) from baseline to study end. MOCA scale runs from 0 to 30 with higher being a better outcome. Change in DSST (Digital Symbol Substitution Test) from baseline to study end. DSST scale runs from 1 to 125 with higher being a better outcome.
Time frame: 6 weeks after randomization and baseline testing
Change in Self-reported Side Effects
Quality of life in Essential Tremor questionnaire (QUEST) Summary Score: A 30-item scale assessing the impact of tremor on various domains of quality of life, such as communication, work and hobbies. In the QUEST questionnaire scale, a lower score is indicative of better quality of life while higher scores indicate poorer quality of life. The score is a percentage ranging from zero to 100.
Time frame: 6 weeks after randomization and baseline testing
Kidney Graft Survival
Number of kidney grafts still functioning at the end of the study
Time frame: 6 months after transplant
Patient Survival
Number patients who survived during the study
Time frame: 6 months after transplant
| Milestone | Immediate Release Tacrolimus | Envarsus |
|---|---|---|
| Started | 32 | 32 |
| Completed | 32 | 32 |
| Not completed | 0 | 0 |
Change in MOCA (Montreal Cognitive Assessment) from baseline to study end. MOCA scale runs from 0 to 30 with higher being a better outcome. Change in DSST (Digital Symbol Substitution Test) from baseline to study end. DSST scale runs from 1 to 125 with higher being a better outcome.
| score on a scale | Immediate Release Tacrolimus | Envarsus |
|---|---|---|
| MOCA score difference | 1.2 ± 2.1 | 0.2 ± 2.9 |
| DSST score difference | 1.0 ± 7.8 | 1.26 ± 7.5 |
Quality of life in Essential Tremor questionnaire (QUEST) Summary Score: A 30-item scale assessing the impact of tremor on various domains of quality of life, such as communication, work and hobbies. In the QUEST questionnaire scale, a lower score is indicative of better quality of life while higher scores indicate poorer quality of life. The score is a percentage ranging from zero to 100.
| score on a scale | Immediate Release Tacrolimus | LCP Tacrolimus |
|---|---|---|
| Change in Self-reported Side Effects | -1.2 ± 7.5 | -3.1 ± 9 |
Number of kidney grafts still functioning at the end of the study
| kidney grafts | Immediate Release Tacrolimus | LCP Tacrolimus |
|---|---|---|
| Kidney Graft Survival | 32 | 32 |
Number patients who survived during the study
| Participants | Immediate Release Tacrolimus | LCP Tacrolimus |
|---|---|---|
| Patient Survival | 32 | 32 |
Collected over While participants were enrolled in the study (6 week period for each individual).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Release Tacrolimus | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Envarsus | 0/32 (0%) | 2/32 (6.3%) | 0/32 (0%) |
| Event | Immediate Release Tacrolimus | Envarsus |
|---|---|---|
| Cognitive declineNervous system disorders | 0/32 | 1/32 |
| Medication OverdoseImmune system disorders | 0/32 | 1/32 |
| Age, Continuous(years) | Immediate Release Tacrolimus | Envarsus | Total |
|---|---|---|---|
| Mean | 69 ± 5.4 | 69 ± 4.2 | 69 ± 4.8 |
| Sex: Female, Male(Participants) | Immediate Release Tacrolimus | Envarsus | Total |
|---|---|---|---|
| Female | 12 | 12 | 24 |
| Male | 20 | 20 | 40 |
| Race/Ethnicity, Customized(Participants) | Immediate Release Tacrolimus | Envarsus | Total |
|---|---|---|---|
| White | 15 | 10 | 25 |
| Black | 0 | 3 | 3 |
| Asian | 4 | 6 | 10 |
| Hispanic | 12 | 7 | 19 |
| Multi-racial | 0 | 1 | 1 |
| Unknown/Other | 1 | 2 | 3 |
| Native Hawaiian / Pacific Islander | 0 | 3 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Apr 2018 to primary completion in Jul 2023, 63 months.
Results were first posted in Apr 2025, 1 year 8 months after primary completion.
Of 18 phase 4 interventional studies under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 37. This study's 63 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tacrolimus
Drug-Related Side Effects and Adverse Reactions →
University of California, Davis →