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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

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ClinicalTrials.gov Identifier: NCT03437577
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Kidney Transplant Failure and Rejection Drug: immediate-release tacrolimus Drug: extended release tacrolimus Phase 1 Phase 2

Detailed Description:

Four (4) 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 at two (2)-three (3) months post-transplant (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 : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: immediate-release tacrolimus
This is standard of care
Drug: immediate-release tacrolimus
Standard of care for transplant patients
Other Name: Prograf
Experimental: extended release tacrolimus
replace standard of care
Drug: extended release tacrolimus
Experimental care
Other Name: Envarsus®XR.



Primary Outcome Measures :
  1. Controlled Oral Word Association [ Time Frame: change from baseline at 6,12, 24 weeks ]
    compare the effect of treatment with an immediate-release tacrolimus (i.e., Prograf®) to an extended-release tacrolimus (Envarsus® XR) immunosuppressive regiment on cognitive and motor function in kidney transplant recipients



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female kidney transplant recipient;
  2. 18-65 years of age;
  3. receiving a kidney transplant from a living or deceased donor;
  4. 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;
  5. written informed consent to participate in the study

Exclusion Criteria:

  1. younger than 18 years of age;
  2. older than 65 years of age;
  3. Non-native level English speaker;
  4. pregnant women
  5. breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437577


Contacts
Contact: Susan Marino, PhD 612-624-2964 marin007@umn.edu

Locations
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Susan Marino, PhD    612-624-2964    marin007@umn.edu   
Principal Investigator: Susan Marino, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Susan Marino, PhD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03437577     History of Changes
Other Study ID Numbers: Marino
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Kidney
Transplant

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action