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Completed

NCT Number: NCT03270462

CNS Study of Patients Switching From Tacrolimus to Envarsus

This is a pilot study documenting the neurotoxic side effects including tremors in patients with a stable graft who are receiving Tacrolimus following kidney transplantation. A standardized questionnaire will be used to document these symptoms.

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Key information

Conditions

Renal Transplant Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lisa Kornfeld

Aurora, Colorado, 80045, United States

About this study

Immunosuppressive therapies have burdensome side effects which may lead to sub-therapeutic dosing and non-compliance.

This study provides renal transplant patients the opportunity for an alternative treatment using tacrolimus, with possible less Central Nervous Symptom (CNS) side effects. CNS side effects are one of the main reasons that patients complain about after having a kidney transplant while on tacrolimus (Prograf). The side effects can be debilitating and can affect the patient's overall well-being. In severe cases it may lead to non-compliance. The advantage of the study of using Envarsus is the ability to avoid these debilitating CNS side effects and afford better compliance with the patients taking the medicine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Kidney transplant recipients with stable graft function.
  • More than 1 months post-transplant.
  • 18+ years of age with some CNS problems secondary to Prograf (tacrolimus).

Exclusion criteria

  • Multi-organ patients (kidney/pancreas, kidney/liver).
  • Evidence of graft rejection or treatment of acute rejection within 14 days prior to baseline visit.
  • Inability to self-administer the QOL questionnaires.

Treatment and study plan

Envarsus XR

Drug

Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.

Other names: Tacrolimus

Primary outcomes

  1. Change in Quality of Life

    Time frame: Baseline, 1 Month, 6 Months

    The Investigators will evaluate the quality of life between baseline and 6 months related to sleep disturbance and upper extremity fine motor skills/ADL (activities of daily living), with the goal to be an improvement in their quality of life. This was assessed via a study-specific clinical assessment that evaluated patient reports of hand tremor and related complaints, and scored in a range of 0 to 3, with higher scores indicating worse symptoms of hand tremor, and a lower QOL.

Secondary outcomes

  1. Therapeutic Tacrolimus Drug Levels

    Time frame: Baseline, 1 Month, 6 Months

    The Investigators will evaluate Tacrolimus drug levels and will document any adverse events associated with this measure.

  2. Kidney Function: Serum Creatinine Levels

    Time frame: Baseline, 1 Month, 6 Months

    The Investigators will evaluate serum creatinine levels and will document any adverse events associated with this measure.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

A Pilot Study of Stable Kidney Transplant Recipients Taking Tacrolimus With CNS Symptoms Switched to Envarsus

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2017
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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