NCT03270462

CNS Study of Patients Switching From Tacrolimus to Envarsus

A Pilot Study of Stable Kidney Transplant Recipients Taking Tacrolimus With CNS Symptoms Switched to Envarsus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplant Patients

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-01
• Primary completion: 2020-05-02
• Completion: 2020-06-02
• First posted: 2017-09-01
• Last updated: 2022-06-02
• Results posted: 2022-06-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study