Phase 4 N=20 Treatment

CNS Study of Patients Switching From Tacrolimus to Envarsus

Renal Transplant Patients

Bottom Line

View on ClinicalTrials.gov: NCT03270462 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Change in Quality of Life — 2.7; 1.35; 0.2 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Envarsus XR (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Quality of Life	2.7; 1.35; 0.2	—
SECONDARY Therapeutic Tacrolimus Drug Levels	8.66; 8.58; 8.48	—
SECONDARY Kidney Function: Serum Creatinine Levels	1.19; 1.14; 1.11	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03270462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.