Clinical trial NCT03461445
Conditions: Kidney Transplant; Complications Toxicity Drug Toxicity Neurotoxicity
Keywords: Elderly Neurotoxicity Calcineurin inhibitors Tacrolimus
Sponsor: University of California, Davis
Start date: 2018-04-01; Completion date: 2023-07-31
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

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.

Arms: arm 1: Patients will receive immediate release tacrolimus arm 2: Patients will be converted to Envarsus formulation of tacrolimus
Interventions: intervention 1: Envarsus intervention 2: IR Tacrolimus
Intervention descriptions: intervention 1: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus intervention 2: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus

Protocol documents:
Prot_SAP_002.pdf: 
Study Title: A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, 
Memory, and Tremor) in Elderly (Age>65) Patients
NCT03461445
Date: November 21, 2018


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1)
Protocol Title
Title:  Evaluating the difference in neurocognitive side effects between tacrolimus IR vs Envarsus XR ® in 
elderly renal transplant recipients. 
Protocol Version Date: 11/21/18 
2)
Objectives
Primary objective: Change in neurocognitive side effects
Secondary Objectives: Change in self-reported side effects, Tacrolimus dose over concentration ratio, 
Graft survival, Patient survival 
Null Hypothesis: Elderly patients will not experience a reduction in neurocognitive side effects when 
transitioned to Envarsus XR ® when compared to elderly patients maintained on tacrolimus IR therapy. 
3)
Background
Renal transplant is widely accepted as the superior treatment for end stage renal disease in 
terms of mortality, morbidity, healthcare cost and quality of life1. Elderly patients (>65 years) 
also benefit from transplantation. Studies have been conducted to evaluate the quality of life 
that elderly transplant recipient’s experience. These studies have demonstrated that in 
appropriate recipients, quality of life is improved post-transplant2. However, the medications 
required to prevent graft rejection come with toxicities that elderly patients may be more 
uniquely sensitive to. 
In particular, neurologic toxicities such as tremor, headaches, confusion and neuropathy are 
common side effects of Tacrolimus immediate release3. When used in combination with 
mycophenolate mofetil, a common immunosuppressant regimen, the incidences of these 
adverse effects are significant4. Per Prograf ® package insert, about one-third of patients 
experience tremors and one-fourth of patients experience headaches4. These neurologic side 
effects may impose profound limitations on patients’ daily activities and quality of life.  These 
studies were conducted in the general population with an average age of 48 years (range 17-77 
years). Elderly patients tend to be more sensitive to medications, both the intended effects and 
the toxicities. The elderly patient experiences changes in organ function and body composition, 
leading to effects on drug metabolism and disposition5. Studies have demonstrated that elderly 
patients achieve higher trough drug levels even when normalizing for patient weight and 
dosage6. In addition, elderly patients tend to have more co-morbidities and are more 
vulnerable to polypharmacy, leading to more potential drug interactions.  All of these factors 
combined may increase the likelihood and severity of toxicities experienced by the elderly 
patient.  


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University of California, Davis Health, is the leading renal transplant center in the nation. In 
2016 alone, over 400 renal transplants were performed. Of those, 72 transplants were in 
patients age 65 years or greater. With about one-fourth of our transplants performed in the 
elderly patient population there is great opportunity to improve outcomes in this patient 
population. The UC Davis Health renal transplant patient population is very diverse, with no one 
ethnicity claiming majority. Between May 2016 and July 2017, 30% of transplant recipients self-
identified as white, 11% as black, 29% as Hispanic, 26% as Asian and 4% as other. As a large 
academic institution, UC Davis Health is well equipped to successfully manage research projects 
and see them to completion. With a dedicated office for research within our campus, research 
coordinators, biostatisticians and other research services available ensures research that is 
conducted at UC Davis Health is robust and valuable to our patients as well as to the broader 
health care audience.  
Our research aims to focus on the neurocognitive effects of Envarsus ® versus tacrolimus 
immediate release. There is a correlation between peak levels of tacrolimus and CNS toxicities 
such as tremor7. As 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 toxicities5,6. Therefore, it is our 
hypothesis that by transitioning patients from tacrolimus immediate release to Envarsus ® we 
will eliminate the peak-dose effect and see a significant decrease in toxicities in the older 
patient population.  
 
References 
1.     Kostro, J,Hellmann, A et al. “Quality of life after kidney transplantation: a prospective study”. Transplant Proc. 48.1 (2016): 
50-54. 
2.     Weber, M, Faravardeh, A et al. “Quality of Life in Elderly Kidney Transplant Recipients.” The American Geriatrics Society. 62 
(2014):1877-1882. 
3.     Tacrolimus. Lxi-Drugs. Lexicomp. Wolter Kluwer Health, Inc. Riverwoods, IL. Accessed July 19,2017. 
4.     Prograf® [package insert]. Northbrook,IL: Atellas Pharmaceuticals 2005. 
5.     Klotz, U. “Pharmacokinetics and drug metabolism in the elderly”41.2(2009):67-76.  
6.     Jacobson, P and Schaldt, D et al. “Lower Calcineurin Inhibitor Doses in Older Compared to Younger Kidney Transplant 
Recipients Yield Similar Troughs.” American Journal of Transplantation 12 (2012):3326–3336 
7.     Langone A, Steinberg SM, Gedaly R, et al. Switching Study of Kidney TRansplant pAtients with Tremor to LCP-TacrO 
(STRATO): an open-label, multicenter, prospective phase 3b study. Clinical Transplantation. 2015;29(9):796-805 
 


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4)          Inclusion and Exclusion Criteria 
Inclusion Criteria:  
1. Recipient of a kidney transplant   
2. Age 65 or greater at the time of transplant  
3. Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant 
4. Have IR tacrolimus as maintenance therapy 
5. Have BMI < 35 at time of transplant 
6. Achieve therapeutic tacrolimus level within 4 weeks post-transplant 
 Exclusion Criteria:  
1. Recipient of a simultaneous non-kidney transplant (pancreas) 
2. Had an episode of rejection before study enrollment 
3. Had a TIA/CVA after transplantation and before study enrollment 
4. Had a neurologic injury after transplantation and before study enrollment 
5. Blindness 
6. Have an mTOR inhibitor as maintenance therapy 
7. Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic 
level with no other rationale for sub-therapeutic levels. 
8. Adults unable to consent 
9. Pregnant women 
10. Prisoners 
  
5)          Study Timelines 
Expected date of data collection and analysis completion by July 2019. 
The duration of an individual subject’s participation in the study is 6-8 weeks from initial study 
enrollment.  
The enrollment period is expected to occur from IRB approval through December 2018, or until 60 
subjects have been enrolled into to the study. 
 
6)          Study Endpoints 
Primary Endpoints: Change in neurocognitive side effects assessed by MOCA scale, Digit symbol 
substitution test and tremor assessment scale. 
Secondary Endpoints: Change in self-reported side effects, tacrolimus dose over concentration ratio, 
graft survival and patient survival.  


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7)          Procedures Involved 
Single-center, prospective, open-label, randomized study to evaluate the difference in 
neurocognitive side effects of Envarsus versus immediate release tacrolimus. 
Figure 1. Flow diagram of study design 
 
Enrollment: 
1. Rolling enrollment of patients 65 years or older that fit the inclusion criteria outlined above 
2. Plan to enroll 30 patients to each arm 
3. Anticipated enrollment rate: 
a. 6-8 patients in first month 
b. 10 patients per month thereafter 
c. Until total of 60 patients have enrolled 
d. If any patients were to withdraw or be dropped from the study prior to completion of 
follow up testing, we will try to enroll more patients to replace them 
 Protocol: 
1. Potential study participants will be screened within 4 weeks after transplantation. 
• 
Patients who meet study criteria will be consented and enrolled by 8 weeks post-
transplantation 
2. Patients who consent to the study will be administered a baseline panel of neurocognitive tests. 
(Of note, these tests are not regularly administered to our post-transplant patients and are not 
part of the standard of care.) 


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• 
Tests include: the MOCA, digit symbol substitution test, tremor assessment.  
• 
They will also answer a side effects questionnaire.  
• 
These tests will be performed in the mornings, between 1-4 hours after patients’ 
morning tacrolimus dose administration. 
3. Subjects who enroll will then be randomized to either remain on IR tacrolimus (current standard 
of care) or be converted to Envarsus.  
• 
Those randomized to Envarsus will begin conversion immediately based on a dosing 
ratio of 0.8 x the total 24-hour IR tacrolimus dose that will lead to therapeutic 
tacrolimus trough levels.  
• 
Therapeutic drug level monitoring and will occur as per usual standard of care for all 
patients. 
• 
Blood draws for all subjects will occur as per usual standard of care and will be managed 
as per usual by the patients' post-transplant team. 
• 
Envarsus to be supplied by the pharmaceutical company. 
• 
IR tacrolimus to be supplied by patient’s insurance 
• 
Any applicable vital signs or labs if collected as patient’s standard of care may be used 
during the study period for study purposes.  
4. Subjects’ tacrolimus levels will be monitored and titrated as per usual practice at our center.  
• 
The target tacrolimus trough is 8-14ng/mL for patients within the first 3 months of 
transplantation.  
• 
They will obtain labs per standard of care (weekly) or at provider discretion. 
• 
Tacrolimus dose adjustment will be made per clinical judgement and expected to reach 
target goal range within 2 blood draws one week apart. (Total of two weeks).  
5. 6 weeks after study enrollment (+/- 5 days), subjects will be administered the same panel of 
neurocognitive testing and self-reported questionnaires as at baseline.  
• 
The tests will be performed in the mornings, between 1-4 hours after patients’ morning 
tacrolimus dose administration. 
• 
At this appointment the patients will receive a $20 check to help with travel expenses 
for additional appointments.  
6. After this study period, subjects who were randomized into the Envarsus arm will be given the 
option to remain on Envarsus or return to IR tacrolimus. Those who remain on Envarsus will be 
part of the extension phase of this study. The funding for the patients’ Envarsus at this phase 
would revert back to their insurance coverage, with potential for coverage by Veloxis if further 
study will be completed (see below). 
7. The extension phase of this study will create a cohort for the assessment of long term graft and 
patient outcomes.  
• 
We anticipate that if sufficient numbers plan to remain on Envarsus, we can apply for 
further funding for this phase. If further funding is approved, we will seek another IRB 
approval for continuation of this study. 


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• 
We do not anticipate long-term data to be collected about subjects beyond their period 
of participation in this study. 
Note: Envarsus is approved by the FDA for use in kidney transplant patients for prevention of rejection. 
Below are the neurocognitive tests that we will perform on each patient. These tests will be 
administered by clinical research coordinators, who will be trained on how to complete each test in 
order to achieve standardized testing practice. 
1. Montreal Cognitive Assessment (MOCA) Test 
a. Available as a paper test or an app (See attachment) 
b. Well researched and accepted in the literature as a measure of mild to moderate 
cognitive impairment8,9 
c. MOCA test version 7.1 will be administered at Day 0, MOCA test version 7.2 will be 
administered at final 6-week visit.   
2. Digit Symbol Substitution (DSS) Test 
a. Available as a paper test or an app (See attachment) 
b. Instrument to measure memory and processing speed10 
3. Tremor Assessment:  
a. Patient Global Impression of Change Scale (PGI) 
b. Clinicial Global Impression of Improvement (CGI) 
c. Both are 7-point scales assessing tremor change. Both were used in STRATO.7 
Below is the self-reported assessment we will use on each patient: 
1.  The Organ Transplant Symptom and Wellbeing Instrument (OTSWI). 
2.  Quality of Life in Essential Tremor Questionnaire (QUEST). 
References 
7.     Langone A, Steinberg SM, Gedaly R, et al. Switching Study of Kidney TRansplant pAtients with Tremor to LCP-TacrO 
(STRATO): an open-label, multicenter, prospective phase 3b study. Clinical Transplantation. 2015;29(9):796-805 
8.     Vichitvejpaisal, P., Preechakoon, B., Supaprom, W., Sriputtaruk, S., Rodpaewpaln, S., Saen-Ubol, R., & Vessuwan, K. (2015). 
The Montreal Cognitive Assessment as a Screening Tool for Preoperative Cognitive Impairment in Geriatric Patients. 
JOURNAL OF THE MEDICAL ASSOCIATION OF THAILAND, 98(8), 782. 
9.     Tiffin-Richards, Frances E., et al. “The Montreal Cognitive Assessment (MoCA)-A Sensitive Screening Instrument for 
Detecting Cognitive Impairment in Chronic Hemodialysis Patients.” PloS one 9.10 (2014): e106700. 
10.   Hoyer, W. J., Stawski, R. S., Wasylyshyn, C., & Verhaeghen, P. (2004). Adult age and digit symbol substitution performance: 
a meta-analysis. Psychology and aging, 19(1), 211. 
8)          Data and/or Specimen Management and Confidentiality 
All individuals with access to participant information will be HIPAA trained and data will be 
stored using password protected computers and accounts. Data will be stored via a secured, 


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encrypted online data management system (REDCap) using password protected computers. 
Due to the nature of the study, we will need to include patient identifiers in the database in 
order to assess adverse events for the duration of the study. The data will be stored until 1 year 
after publication of the study. 
Data analysis plan: We will compare the neurocognitive scores between the Envarsus and IR 
Tacrolimus arms of the study. Sample size calcuation was done to determine sample size 
needed to detect a 1 point difference for each neurocognitive test we plan to use. The two 
groups will be compared using two-sample mean comparison via t test.  
We will not be collecting or banking any patient specimens for this study. 
 
9)           Data and/or Specimen Banking 
Participant data will be stored for potential future use by the PI and co-PIs pending further IRB approval. 
Data will only be released upon approval of PI with IRB approval. Data will be stored on encrypted 
devices requiring password protection. Passwords will not be shared by any users. Paper records of 
patient testing will be stored in locked cabinets with access only by research staff.  
  
10)     Provisions to Monitor the Data to Ensure the Safety of Subjects 
Data will be extracted from the EMR and stored in a password protected folder on a secure, encrypted 
network. This network is only accessible by staff at UC Davis Health. This password protected folder will 
only be authorized to be accessed by study personnel. When this data is removed from this folder such 
as for the purposes of data analysis, each patient’s data will be coded with a de-identified number. The 
identified patient information stored in the protected file will be destroyed at the end of this study. 
For the duration of a subject's participation in the study, their clinical events and laboratory values will 
be monitored for any adverse events, including acute rejection, surgical complication, infections, 
cardiovascular events, neurologic events, and other events or side effects that may potentially be 
related to IR tacrolimus or Envarsus therapy. These data will be reviewed by the PI and co-PIs to 
determine if they are the direct result of use of the investigational drug. 
Once 50% of total enrollment is reached, the proportion of each arm with either acute rejection or sub-
therapeutic tacrolimus trough levels will be compared. If there is a significant difference (p < 0.05) 
between the two arms in terms of rejection or sub-therapeutic tacrolimus trough (level < 8), the PI and 
co-PI may choose to terminate the study early. 
11)     Withdrawal of Subjects 
Discontinuation criteria from study for individual subjects: 


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• 
Subject develops allograft loss (as defined by subject death, re-transplantation, transplant 
nephrectomy, or return to dialysis) within the period of their study participation 
• 
Subject develops unacceptable toxicity or is withdrawn at the discretion of the patient’s 
supervising physician 
• 
Subject is lost to follow-up despite reasonable efforts by the investigator to locate the subject 
• 
Subject withdraws consent for further treatment or expires during the course of the study 
• 
Subject begins taking any prohibited medications 
• 
Subject develops a severe neurologic condition (ie – stroke, neurologic injury, blindness, or 
other incapacitating event) that prevents further neurocognitive testing during the period of 
their enrollment in the study. 
• 
Conversion to a non-tacrolimus-based maintenance regimen in either study arm if required to 
• 
manage toxicities 
• 
With regard to patients receiving Envarsus, an inability to maintain a tacrolimus trough 
concentration >8 ng/mL for > 2 consecutive weeks during the course of the study, or conversion 
to twice-daily, immediate-release Tacrolimus 
• 
With regard to patients receiving immediate-release tacrolimus, an inability to maintain a 
tacrolimus trough concentration >8 ng/mL for > 2 consecutive weeks during the course of the 
study, or conversion to Astagraf XL or Envarsus. 
• 
Patients meeting inclusion criteria at time of randomization and not initiated on Envarsus or 
immediate-release tacrolimus within 7 days of study enrollment will be classified as a 
recruitment failure and not included in the full analysis set (FAS) or per protocol set (PPS) 
analysis. 
 
Individuals who were enrolled in the study and completed their initial neurocognitive assessment but 
were not able to complete their follow up assessment due to any of the above will still be included in 
the baseline testing results. These individuals' further clinical data will not be collected upon their 
termination from the study. 
Individuals who were initially randomized to the Envarsus study arm whose participation is terminated 
at any point after their study enrollment will be converted back to IR tacrolimus as per usual conversion 
dosing.  
12)     Risks to Subjects 
This study poses minimal risk to subjects. Envarsus has equivalent rates of rejection compared with IR 
tacrolimus in large controlled trials so we do not anticipate subjects to be at any increased risk as a 
result of taking Envarsus. Subjects will, however, need to spend more time in transplant clinic 
undergoing the testing needed for the study. This may mean more visits to the transplant center for the 
duration of their participation in the study. 
This study also poses an unlikely and minimal risk of breach of confidentiality. The risk of loss of 
confidentiality will be minimized by assigning a unique study ID number to the patient at the time of 
study entry. Study information stored by the research personnel at UCDMC, which may include name 


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and medical record number, will be kept strictly confidential and only available to the principal 
investigator and trained staff assigned to this study. All information will be kept secure in locked file 
cabinets accessible only by research personnel. 
13)     Potential Benefits to Subjects 
The study will provide each enrolled patient $20 at the beginning and $20 at the end to compensate 
them for the time and effort they spend participating in this study. There is a potential benefit for those 
patients randomized to the Envarsus if there are any improved neurocognitive side effects lessened by 
Envarsus as opposed to IR tacrolimus.  
14)     Multi-Site Research 
N/A 
15)     Community-Based Participatory Research 
N/A 
16)     Sharing of Results with Subjects 
Results will not be shared with the subjects. The testing that is part of the study do not impact clinical 
care. 
17)     Prior Approvals 
Funding from Veloxis will be obtained prior to conducting this study.  
18)     Provisions to Protect the Privacy Interests of Subjects 
Only research personnel who are HIPAA trained will interact with patients or have access to their 
records. All patient interactions will occur in the privacy of dedicated exam and interview rooms that 
provide confidentiality. All subjects will be informed in advance (at the time of consent) of the types of 
questions we will be asking for the study and the information that we will be obtaining upon study 
follow up.  
19)     Compensation for Research-Related Injury 
N/A 
20)     Economic Burden to Subjects 
Participating in this study may involve additional clinic appts which may pose a financial burden to the 
patient in terms of time away from home/work. To minimize the financial burden to the patient, the 
study will provide transportation stipends  to the patients participating in this study.  
21)     Drugs or Devices 


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☐ I confirm that all investigational drugs will be received by the Investigational Drug Service (IDS).  The 
IDS will store, handle, and administer those drugs so that they will be used only on subjects and be used 
only by authorized investigators. 
  
☐ I confirm that all investigational devices will be labelled in accordance with FDA regulations 
and stored and dispensed in such a manner that they will be used only on subjects and be used 
only by authorized investigators. 
  
22)     ClinicalTrials.gov Registration 
  
Section 1:  NIH Funded Studies 
If yes to BOTH, the study must be registered on Clinicaltrials.gov. 
 
  
NO 
This study is funded by the NIH. (If this study is 
not funded by NIH, go to Section 2.) 
YES 
One or more human subjects will be 
prospectively assigned to one or more 
interventions (which may include placebo or 
other control) to evaluate the effects of those 
interventions on health-related biomedical or 
behavioral outcomes. 
  
Section 2:  Studies subject to FDA jurisdiction 
If yes to ANY the study must be registered on Clinicaltrials.gov. 
 
  
no 
This is a prospective clinical study of health 
outcomes in human subjects that compares an 
intervention with an FDA-regulated device 
against a control. This is not a small clinical trial 
to determine the feasibility of a device, or a 
clinical trial to test prototype devices where the 
primary outcome measure relates to feasibility 
and not to health outcomes. 


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no 
This is a pediatric postmarket surveillance of a 
device as required under section 522 of the 
Federal Food, Drug, and Cosmetic Act. 
no 
This is a controlled clinical investigation, other 
than a phase I clinical investigation, of a drug 
subject to section 505 of the Federal Food, Drug, 
and Cosmetic Act or to section 351 of the Public 
Health Service Act. 
To view a flowchart describing applicable clinical trials subject to FDA jurisdiction click here. 
  
Section 3: Publishing the results 
If yes to BOTH the study must be registered on Clinicaltrials.gov. 
 
  
YES 
This study prospectively assigns people or a 
group of people to an intervention, with or 
without concurrent comparison or control 
groups, to study the cause-and-effect 
relationship between a health-related 
intervention and a health outcome. 
YES 
The PI has access to and control over all the data 
from the clinical trial and has the right to publish 
the results of the trial and plans to publish the 
results in a journal that follows the ICMJE 
recommendations.  
This requirement includes studies of behavioral interventions. 
  
Section 4: Registration on Clinicaltrials.gov is not required 
 
  
NO 
I have read sections 1-3 above and registration 
on clinicaltrials.gov is not required for this 
research.  
  
23)     Criteria for 10 Year Approval  
If yes to all items below this research may qualify for a 10-year approval period.  
Yes 
  
No 
This research involves no more than minimal risk. 


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yes 
This research does not receive any federal or 
state government funding or funding from a 
private funder who requires annual review per 
contract. 
No 
This research is not subject to FDA jurisdiction.  
yes 
This research does not include prisoners as 
participants. 
yes 
This research is not subject to SCRO oversight. 
yes 
This research is not subject to oversight by the 
Research Advisory Panel of California (RAP of C). 
yes 
This research does not involve identifiable 
information held by the State of California 
Department or Agency 
yes 
No personnel involved in the design, conduct, or 
reporting of this research have a new unreported 
related financial interest (RFI) in this study.