- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04838288
Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™ (OPERATOR)
Cognitive Outcomes and Quality of Life in Stable Renal Transplant Patients Switched fromTwice-Daily Tacrolimus to Envarsus XR™
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Mohammed Sika, PhD
- Phone Number: 6159361179
- Email: mohammed.sika@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- VUMC
-
Contact:
- Mohammed Sika, PhD
- Phone Number: 615-936-2630
- Email: mohammed.sika@vumc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must be able to understand English and provide written informed consent;
- Males and females between 18 and 70 years of age;
- Recipients of a primary or secondary kidney transplant 4 weeks to 10 years prior to screening;
- Patients receiving a stable dose (i.e., no dose adjustments) of TAC-IR for a minimum of 4-7 days at screening;
- Patients with a screening TAC-IR trough level of 3-9 ng/mL, measured between Day -7 to 0;
- Women of childbearing potential must have a negative urine pregnancy test at screening;
- Patients must be willing to commit to and comply with the schedule of study visits.
- The patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit and pomegranate products), or medications listed in Appendix 1.
Exclusion Criteria:
- Recipients of any transplanted organ other than kidney;
- Patients with an estimated glomerular filtration rate (eGFR) (MDRD4) < 25 mL/min at screening;
- Patients with significant visual impairments affecting their ability to complete the study requirements and assessments: patient's vision is 20/200 or worse;
- Patients with significant hearing impairments affecting their ability to complete the study requirements and assessments, based on Investigator discretion;
- Patients with any severe medical condition (including infection) requiring acute or chronic treatment that in the Investigator's opinion would interfere with study participation;
Patients who have a history of any of the following, based on documentation of clinical conditions and concomitant medications in the medical records:
- Cognitive decline secondary to stroke, per Investigator discretion
- Dementia
- Resected or existing brain tumor
- Acute or chronic bipolar psychosis or schizophrenia per Investigator discretion
- Mental retardation
- Moderate or severe traumatic brain injury
- Failure of any major organ other than the kidneys (e.g., end-stage liver disease)
- Known non-adherence (defined as documentation in the patient chart of multiple missed visits and/or medication doses) which in the Investigator's opinion would interfere with the objectives of the study
- Patients with medical history of hypertension or diabetes which is unmanageable by medically approved intervention (e.g., medication/diet) as assessed by the Investigator;
- Patients with acute or chronic depression, corresponding to a score of ≥20 (corresponding to moderate depression) on the BDI-II at screening;
- Patients who are taking any acute or chronic medications that may impact reaction time, memory, or sleep habits, based on Investigator discretion;
- Patients on concurrent immunosuppression with MMF (CellCept) or MPS delayed release tablets (Myfortic), or generic versions of these medications, as per SOC, who have not been on stable doses (i.e., no dose adjustments or formulation change) for at least 4-7 days prior to screening;
- Patients receiving prednisone or equivalent >10 mg/day;
- Patients with an episode of biopsy-proven or suspected acute rejection that requires treatment within 3 months of screening;
- Patients who are being actively treated for cancer (with the exception of non-invasive basal cell or cutaneous squamous cell carcinoma);
- Patients known to be human immunodeficiency virus (HIV) positive;
- Patients with any form of current drug or alcohol abuse as assessed by the Investigator;
- Patients who were treated with any other investigational agent within 1 month prior to screening;
Pregnant or nursing women or women planning to become pregnant, where pregnancy is defined as a state of the female patient after conception and until the termination of gestation, confirmed by a positive urine laboratory test; women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC birth control method; UNLESS they are:
- Women whose career, lifestyle, or sexual orientation preclude intercourse with a partner
- Women whose partners have been sterilized by medically approved means
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Change from Prograf to Envarsus
All participants will be switched from Prograf to Envarsus
|
Change from Tacrolimus taken twice a day to Envarsus XR taken once a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive function-Global on RBANS
Time Frame: Baseline to month 4
|
Measured by the Global Composite Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Total score can range from 40 to 160.
Low score indicates cognitive impairment.
|
Baseline to month 4
|
Change in cognitive function-Global on Covid-19 telephone battery
Time Frame: Baseline to month 4
|
Measured by the global composite score of the Covid-19 Telephone Battery, should that be the primary outcome battery that we employ due to COVID limitation.
Total score can range from 40 to 160.
Low score indicates cognitive impairment.
|
Baseline to month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive function on Trail making part A
Time Frame: Baseline to month 4
|
Measured by Trail making Part A. Maximum time given for TMT A is 150 seconds.
Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
|
Baseline to month 4
|
Change in cognitive function on Trail making part B
Time Frame: Baseline to month 4
|
Measured by Trail making Part B. Maximum time given for TMT B is 300 seconds.
Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
|
Baseline to month 4
|
Change in quality of life
Time Frame: Baseline to Month 4
|
Change in quality of life measured by WHODAS.
The total score of WHODAS is the sum of all the 12 sub-scores and ranges from 0 to 48, with lower scores indicating better functioning.
Total scores of 1-4 belong to mild disability, 5-9 to moderate disability, and 10-48 to severe disability
|
Baseline to Month 4
|
Impression of Improvement by PGI
Time Frame: baseline to month 4
|
measured by PGI-I (Patient's Global Impression of Improvement).
The PGI-I measures change since initiating a medication and is assessed on a 7-point Likert-type scale ranging from very much better (1) to very much worse (7)
|
baseline to month 4
|
Impression of Improvement by CGI
Time Frame: baseline to month 4
|
measured by CGI-I (Clinical Global Impression of Improvement).
The CGI-I measures change since initiating a medication and is assessed on a 7-point Likert-type scale ranging from very much improved (1) to very much worse (7).
|
baseline to month 4
|
Change of quality of sleep
Time Frame: Baseline to month 4
|
measured by PIRS-20 (Pittsburgh Insomnia Rating Scale).
The PIRS-20 total score is the sum of all items and ranges from 0 (good sleep) to 60 (bad sleep).3
|
Baseline to month 4
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anthonny Langone, MD, VUMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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