- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437577
Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Between four (4) months and 14 months after receiving a kidney transplant and, per standard of care (SOC), having been placed on an immediate-release (IR) tacrolimus immunosuppressant regimen, participants in this study will undergo cognitive and motor function testing and have a blood sample collected (BASELINE). Half of the participants will then be randomly converted to extended-release (XR) tacrolimus (Envarsus® XR) while the other half will remain on IR tacrolimus for the duration of the study. Both the IR and XR groups will repeat the cognitive and motor function testing and have a blood sample collected at 6, 12, and 24 weeks Post-BASELINE. A practice version of the cognitive and motor function tests will be administered no more than 60 days prior to the baseline visit (Pre-BASELINE). Alternate versions of the cognitive and motor tests will be used at each Post-BASELINE testing session to control for possible practice effects.
The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney transplant recipients.
The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used. Measurement of drug concentration will be the dependent variable.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female kidney transplant recipient;
- 18-65 years of age;
- receiving a kidney transplant from a living or deceased donor;
- if female, premenopausal and heterosexually active, must be using two forms of highly effective birth control (at least one of which must be a barrier method) which includes consistent and correct usage of established oral contraception, established intrauterine device or intrauterine system, or barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, starting at screening and throughout the study period and for 90 days after the final study drug administration;
- written informed consent to participate in the study
Exclusion Criteria:
- younger than 18 years of age;
- older than 65 years of age;
- Non-native level English speaker;
- pregnant women
- breastfeeding women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: immediate-release tacrolimus
This is standard of care
|
Standard of care for transplant patients
Other Names:
|
Experimental: extended release tacrolimus
replace standard of care
|
Experimental care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Controlled Oral Word Association Test (COWAT)
Time Frame: Change from baseline at 6,12, 24 weeks
|
During The Controlled Oral Word Association Test (COWAT), participants are asked to make verbal associations to different letters of the alphabet by saying all the words which they can think of beginning with a given letter.
Three letters of progressively increasing associative difficulty are presented with 60 seconds allotted per letter for word retrieval.
Scores are calculated as a sum of the total words produced across the 3 letter trials.
The lowest possible score is zero, meaning no words could be produced.
There is no limit to the higher end of the scale given that participants can produce as many words as possible for each of the three letters.
Higher scores indicate greater word retrieval and better cognitive function.
Outcome is reported as the change in COWAT between baseline and 6 weeks, baseline and 12 weeks, and baseline and 24 weeks.
|
Change from baseline at 6,12, 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan Marino, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- PHARM-2017-25529
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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