Status:
COMPLETED
CNS Study of Patients Switching From Tacrolimus to Envarsus
Lead Sponsor:
University of Colorado, Denver
Conditions:
Renal Transplant Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 questionna...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03270462
Start Date
December 1 2017
End Date
June 2 2020
Last Update
June 2 2022
Active Locations (1)
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1
Lisa Kornfeld
Aurora, Colorado, United States, 80045