CNS Study of Patients Switching From Tacrolimus to Envarsus

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT03270462
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 30
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant Patients	Drug: Envarsus XR	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Stable Kidney Transplant Recipients Taking Tacrolimus With CNS Symptoms Switched to Envarsus
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: May 2, 2020
• Actual Study Completion Date: Jun 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Envarsus XR A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.	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.; Other Names: Tacrolimus

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lisa Kornfeld	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Laurence Chan, MD, University of Colorado, Denver

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 15, 2017

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03270462
• Other Study ID Numbers: 17-0781
• First Posted: Sep 1, 2017
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Tacrolimus

Study Results

Participant Flow

Arm/Group Title	Envarsus XR
Arm/Group Description	A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. 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.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Envarsus XR
Arm/Group Description	A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. 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.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 75%
>=65 years	5 25%
Sex: Female, Male (Count of Participants)
Female	10 50%
Male	10 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5%
Not Hispanic or Latino	19 95%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 15%
White	15 75%
More than one race	1 5%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Change in Quality of Life
Description	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.
Time Frame	Baseline, 1 Month, 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Envarsus XR
Arm/Group Description	A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. 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.
Measure Participants	20
Baseline	2.7
Month 1	1.35
Month 6	0.2

2. Secondary Outcome

Title	Therapeutic Tacrolimus Drug Levels
Description	The Investigators will evaluate Tacrolimus drug levels and will document any adverse events associated with this measure.
Time Frame	Baseline, 1 Month, 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Envarsus XR
Arm/Group Description	A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. 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.
Measure Participants	20
Baseline	8.66 (2.71)
Month 1	8.58 (1.75)
Month 6	8.48 (2.43)

3. Secondary Outcome

Title	Kidney Function: Serum Creatinine Levels
Description	The Investigators will evaluate serum creatinine levels and will document any adverse events associated with this measure.
Time Frame	Baseline, 1 Month, 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Envarsus XR
Arm/Group Description	A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. 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.
Measure Participants	20
Baseline	1.19 (0.31)
Month 1	1.14 (0.34)
Month 6	1.11 (0.35)

Adverse Events

Time Frame	6 months
Arm/Group Title	Envarsus XR
Arm/Group Description	A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. 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.
All Cause Mortality
	Envarsus XR
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Envarsus XR
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Envarsus XR
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.