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NCT03437577 · ClinicalTrials.gov registry record · Phase 1

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 study, sponsored by University of Minnesota.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT03437577: Completed Phase 1 study, sponsored by University of Minnesota.

NCT03437577 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03437577, a Phase 1 study, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study 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

Primary Outcome

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 c

Interventions

  • DRUG immediate-release tacrolimus
  • DRUG extended release tacrolimus

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2018-05-08
Est. Completion 2020-03-31
Phase Phase 1
University of Minnesota

966 total trials

What the finished NCT03437577 record still lists

NCT03437577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which immediate-release tacrolimus is the first listed.

NCT03437577 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03437577 about?

NCT03437577 is a clinical study titled "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". 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

What is the current status of trial NCT03437577?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-05-08. Estimated completion is 2020-03-31.

What interventions are being tested in trial NCT03437577?

The interventions under investigation include: immediate-release tacrolimus (DRUG), extended release tacrolimus (DRUG).

Who is sponsoring clinical trial NCT03437577?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03437577's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03437577, the US trial registry maintained by the National Library of Medicine. NCT03437577 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.