CNS Study of Patients Switching From Tacrolimus to Envarsus

NCT03270462 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-0781
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Therapeutic Tacrolimus Drug Levels

  Baseline, 1 Month, 6 Months

• Kidney Function: Serum Creatinine Levels

  Baseline, 1 Month, 6 Months

Study Arms (1)

Envarsus XR

OTHER

A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.

Drug: Envarsus XR

Interventions

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.

Also known as: Tacrolimus

Envarsus XR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Lisa Kornfeld

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Larry Chan
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Laurence Chan, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: September 1, 2017
• Study Start: December 1, 2017
• Primary Completion: May 2, 2020
• Study Completion: June 2, 2020
• Last Updated: June 2, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)