CNS Study of Patients Switching From Tacrolimus to Envarsus
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/2/2017 |
| Start Date: | October 2017 |
| End Date: | December 2019 |
| Contact: | Janis Cicerchi, ANP |
| Email: | janis.cicerchi@ucdenver.edu |
| Phone: | 303-724-0183 |
A Pilot Study of Stable Kidney Transplant Recipients Taking Tacrolimus With CNS Symptoms Switched to Envarsus
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.
with a stable graft who are receiving Tacrolimus following kidney transplantation. A
standardized questionnaire will be used to document these symptoms.
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.
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.
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.
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Laurence Chan, MD
Phone: 303-724-0183
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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