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

NCT03437577 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: PHARM-2017-25529
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Transplant Failure and Rejection

Keywords

Kidney; Transplant

Outcome Measures

Primary Outcomes (1)

• Change in Controlled Oral Word Association Test (COWAT)

  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

Study Arms (2)

immediate-release tacrolimus

ACTIVE COMPARATOR

This is standard of care

Drug: immediate-release tacrolimus

extended release tacrolimus

EXPERIMENTAL

replace standard of care

Drug: extended release tacrolimus

Interventions

immediate-release tacrolimus DRUG

Standard of care for transplant patients

Also known as: Prograf

immediate-release tacrolimus

extended release tacrolimus DRUG

Experimental care

Also known as: Envarsus®XR.

extended release tacrolimus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female kidney transplant recipient;
• 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

You may not qualify if:

• younger than 18 years of age;
• older than 65 years of age;
• Non-native level English speaker;
• pregnant women
• breastfeeding women

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Susan Marino
• Organization: University of Minnesota

marin007@umn.edu

612-624-2964

Study Officials

• Susan Marino, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: May 8, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 15, 2021
• Results First Posted: April 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)