Kidney Transplant; ComplicationsPhase 4NCT03461445
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
A Phase 4 study testing Envarsus and IR Tacrolimus in people with Kidney Transplant; Complications and Toxicity, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Toxicity, Drug Toxicity
- What is being tested?
- Envarsus and IR Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 31 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient of a kidney transplant
- Age 60 or greater at the time of transplant
- Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
- Have IR tacrolimus as maintenance therapy
- Have BMI < 35 at time of transplant
- Achieve therapeutic tacrolimus level within 4 weeks post-transplant
Who cannot join
- Recipient of a simultaneous non-kidney transplant (pancreas)
- Had an episode of rejection before study enrollment
- Had a TIA/CVA after transplantation and before study enrollment
- Had a neurologic injury after transplantation and before study enrollment
- Blindness
- Have an mTOR inhibitor as maintenance therapy
Show all 10Show fewer
- Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels.
- Adults unable to consent
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
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.
Read the detailed 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.
- Being tested
- Envarsus, IR Tacrolimus
- Keywords
- Elderly, Neurotoxicity, Calcineurin inhibitors, Tacrolimus
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvarsusDrug
Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
IR TacrolimusDrug
Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
| Study group | Role | What they receive |
|---|---|---|
| Immediate Release Tacrolimus | Active comparator | Patients will receive immediate release tacrolimus Receives: Drug: IR Tacrolimus |
| Envarsus | Experimental | Patients will be converted to Envarsus formulation of tacrolimus Receives: Drug: Envarsus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after randomization and baseline testing
Secondary outcomes (3)
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.
Measured: 6 weeks after randomization and baseline testing
Kidney Graft Survival
Number of kidney grafts still functioning at the end of the study
Measured: 6 months after transplant
Patient Survival
Number patients who survived during the study
Measured: 6 months after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Apr 2018
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Ling-Xin Chen, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461445
- Sponsor's protocol ID
- 1044220
- Status last verified
- Apr 2025
- First submitted
- 5 Mar 2018
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
- ClinicalTrials.gov ID
- NCT03461445
- Acronym / sponsor ID
- 1044220
- Keywords
- Elderly, Neurotoxicity, Calcineurin inhibitors, Tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Release Tacrolimus | Active comparator | Drug: IR TacrolimusPatients will receive immediate release tacrolimus |
| Envarsus | Experimental | Drug: EnvarsusPatients will be converted to Envarsus formulation of tacrolimus |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recipient of a kidney transplant
- Age 60 or greater at the time of transplant
- Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
- Have IR tacrolimus as maintenance therapy
- Have BMI < 35 at time of transplant
Key exclusion criteria (10 listed)
- Recipient of a simultaneous non-kidney transplant (pancreas)
- Had an episode of rejection before study enrollment
- Had a TIA/CVA after transplantation and before study enrollment
- Had a neurologic injury after transplantation and before study enrollment
- Blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnvarsusPatients will be randomized to receiving Envarsus instead of IR Tacrolimus | Drug | Envarsus |
| IR TacrolimusPatients will be randomized to receiving IR Tacrolimus instead of Envarsus | Drug | Immediate Release Tacrolimus |
Primary outcome
Change in Neurocognitive Side Effects
Time frame: 6 weeks after randomization and baseline testing
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.
3 secondary outcomes
Change in Self-reported Side Effects
Time frame: 6 weeks after randomization and baseline testing
Kidney Graft Survival
Time frame: 6 months after transplant
Patient Survival
Time frame: 6 months after transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling-Xin Chen, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Envarsus and IR Tacrolimus in people with Kidney Transplant; Complications and Toxicity, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neurocognitive Side Effects (time frame: 6 weeks after randomization and baseline testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.