CNS Study of Patients Switching From Tacrolimus to Envarsus

Phase 4

Completed

• Conditions: Renal Transplant Patients
• Interventions: Drug: Envarsus XR

• Registration Number: NCT03270462
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-09-01
• Study Start: 2017-12-01
• Primary Completion: 2020-05-02
• Study Completion: 2020-06-02
• Status Verified: 2022-05
• Results First Submitted: 2022-05-09
• Results First Submitted QC: 2022-05-10
• Last Update Submitted: 2022-05-10
• Results First Posted: 2022-06-02
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Envarsus XR	Envarsus XR	A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life	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 Outcome Measures

Name	Time	Method
Therapeutic Tacrolimus Drug Levels	Baseline, 1 Month, 6 Months	The Investigators will evaluate Tacrolimus drug levels and will document any adverse events associated with this measure.
Kidney Function: Serum Creatinine Levels	Baseline, 1 Month, 6 Months	The Investigators will evaluate serum creatinine levels and will document any adverse events associated with this measure.

Trial Locations

Locations (1)

Lisa Kornfeld; 🇺🇸 Aurora, Colorado, United States