CNS Study of Patients Switching From Tacrolimus to Envarsus
NCT ID: NCT03270462
Last Updated: 2022-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2017-12-01
2020-06-02
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Envarsus XR
A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* More than 1 months post-transplant.
* 18+ years of age with some CNS problems secondary to Prograf (tacrolimus).
Exclusion Criteria
* Evidence of graft rejection or treatment of acute rejection within 14 days prior to baseline visit.
* Inability to self-administer the QOL questionnaires.
18 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Laurence Chan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Lisa Kornfeld
Aurora, Colorado, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-0781
Identifier Type: -
Identifier Source: org_study_id
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