NCT03270462

CNS Study of Patients Switching From Tacrolimus to Envarsus

Completed Phase 4 Results posted Last updated 2 June 2022

What this trial tests

Phase 4 trial testing Envarsus XR in Renal Transplant Patients in 20 participants. Completed in 2 June 2020.

Timeline

1 December 2017

Primary endpoint
2 May 2020

2 June 2020

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 December 2017
Primary completion	2 May 2020
Estimated completion	2 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Envarsus XR

Conditions studied

• Renal Transplant Patients — all drugs for Renal Transplant Patients →

Sponsor

University of Colorado, Denver

Who can join

18 and older, any sex, with Renal Transplant Patients. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Quality of Life Primary · 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.

Baseline

Group	Value	95% CI
Envarsus XR	2.7	2 – 3

Month 1

Group	Value	95% CI
Envarsus XR	1.35	0 – 2

Month 6

Group	Value	95% CI
Envarsus XR	0.2	0 – 1

Therapeutic Tacrolimus Drug Levels Secondary · Baseline, 1 Month, 6 Months

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

Baseline

Group	Value	95% CI
Envarsus XR	8.66	± 2.71

Month 1

Group	Value	95% CI
Envarsus XR	8.58	± 1.75

Month 6

Group	Value	95% CI
Envarsus XR	8.48	± 2.43

Kidney Function: Serum Creatinine Levels Secondary · Baseline, 1 Month, 6 Months

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

Baseline

Group	Value	95% CI
Envarsus XR	1.19	± 0.31

Month 1

Group	Value	95% CI
Envarsus XR	1.14	± 0.34

Month 6

Group	Value	95% CI
Envarsus XR	1.11	± 0.35

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.