Kidney Transplant Failure and RejectionPhase 1/2NCT03437577

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

A Phase 1/2 study testing immediate-release tacrolimus and extended release tacrolimus in people with Kidney Transplant Failure and Rejection, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Kidney Transplant Failure and Rejection
What is being tested?: immediate-release tacrolimus and extended release tacrolimus
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 8 May 2018to 31 Mar 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55414

Other trials in United States

About this study

Read the 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 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.

Conditions: Kidney Transplant Failure and Rejection
Being tested: immediate-release tacrolimus, extended release tacrolimus
Keywords: Kidney, Transplant
Medical subject headings: Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

immediate-release tacrolimusDrug
Also called Prograf
Standard of care for transplant patients
extended release tacrolimusDrug
Also called Envarsus®XR.
Experimental care

Study groups in NCT03437577
Study group	Role	What they receive
immediate-release tacrolimus	Active comparator	This is standard of care Receives: Drug: immediate-release tacrolimus
extended release tacrolimus	Experimental	replace standard of care Receives: Drug: extended release tacrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline at 6,12, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 201831 Mar 2020

First posted19 Feb 2018
Study start8 May 2018
Primary completion31 Mar 2020
Study completion31 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03437577
Sponsor's protocol ID: PHARM-2017-25529
Status last verified: Mar 2021
First submitted: 12 Feb 2018
Last updated: 15 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
Renal Transplant Failure and Rejection
Not yet recruitingPhase 1
ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
Kidney Transplant Failure and Rejection, Kidney Transplant; Complications
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation

All Kidney Transplant Failure and Rejection trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03437577
Acronym / sponsor ID: PHARM-2017-25529
Conditions: Kidney Transplant Failure and Rejection
Keywords: Kidney, Transplant
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 8 May 2018 (actual)
Primary completion: 31 Mar 2020 (actual)
Study completion: 31 Mar 2020 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 15 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
immediate-release tacrolimus	Active comparator	Drug: immediate-release tacrolimusThis is standard of care
extended release tacrolimus	Experimental	Drug: extended release tacrolimusreplace standard of care

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
immediate-release tacrolimusAlso: PrografStandard of care for transplant patients	Drug	immediate-release tacrolimus
extended release tacrolimusAlso: Envarsus®XR.Experimental care	Drug	extended release tacrolimus

Primary outcome

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.

Results and safety

Results posted to the registry on 15 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate-Release Tacrolimus	0	0
Extended-Release Tacrolimus	0	0
Non-Randomized	10	0

Primary outcome: Change in Controlled Oral Word Association Test (COWAT)

Time frame: Change from baseline at 6,12, 24 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Immediate-Release Tacrolimus n = 3	Extended-Release Tacrolimus n = 5
Baseline to 6 weeks	.44 (.51)	-2.11 (2.83)
Baseline to 12 weeks	-0.88 (1.89)	-1.78 (2.01)
Basline to 24 weeks	0.78 (.84)	-0.44 (2.04)

Population analysed: All participants who were randomized and participated in outcome measure data collection are included.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate-Release Tacrolimus	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Extended-Release Tacrolimus	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Kidney Transplant Failure and Rejection

Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
Renal Transplant Failure and Rejection
Not yet recruitingPhase 1
ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
Kidney Transplant Failure and Rejection, Kidney Transplant; Complications
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Marino, PhD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Controlled Oral Word Association Test (COWAT) (time frame: Change from baseline at 6,12, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03437577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.