CNS Study of Patients Switching From Tacrolimus to Envarsus

Renal Transplant Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270462
• Other study ID #: 17-0781
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: June 2, 2020

Study information

• Verified date: May 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2, 2020
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Renal Transplant Patients

Intervention

Drug:
• Envarsus XR
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.

Locations

Country	Name	City	State
United States	Lisa Kornfeld	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life	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.	Baseline, 1 Month, 6 Months
Secondary	Therapeutic Tacrolimus Drug Levels	The Investigators will evaluate Tacrolimus drug levels and will document any adverse events associated with this measure.	Baseline, 1 Month, 6 Months
Secondary	Kidney Function: Serum Creatinine Levels	The Investigators will evaluate serum creatinine levels and will document any adverse events associated with this measure.	Baseline, 1 Month, 6 Months