A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
Primary Purpose
Kidney Transplant; Complications, Toxicity, Drug Toxicity
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Envarsus
IR Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplant; Complications focused on measuring Elderly, Neurotoxicity, Calcineurin inhibitors, Tacrolimus
Eligibility Criteria
Inclusion Criteria:
- Recipient of a kidney transplant
- Age 60 or greater at the time of transplant
- Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
- Have IR tacrolimus as maintenance therapy
- Have BMI < 35 at time of transplant
- Achieve therapeutic tacrolimus level within 4 weeks post-transplant
Exclusion Criteria:
- Recipient of a simultaneous non-kidney transplant (pancreas)
- Had an episode of rejection before study enrollment
- Had a TIA/CVA after transplantation and before study enrollment
- Had a neurologic injury after transplantation and before study enrollment
- Blindness
- Have an mTOR inhibitor as maintenance therapy
- Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels.
- Adults unable to consent
- Pregnant women
- Prisoners
Sites / Locations
- UC DavisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Immediate Release Tacrolimus
Envarsus
Arm Description
Patients will receive immediate release tacrolimus
Patients will be converted to Envarsus formulation of tacrolimus
Outcomes
Primary Outcome Measures
Change in neurocognitive side effects
Secondary Outcome Measures
Change in self-reported side effects
Tacrolimus dose over concentration ratio
Kidney graft survival
Patient survival
Full Information
NCT ID
NCT03461445
First Posted
March 5, 2018
Last Updated
November 15, 2022
Sponsor
University of California, Davis
Collaborators
Veloxis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03461445
Brief Title
A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
Official Title
A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Veloxis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.
Detailed Description
The investigators will conduct a single-center, prospective, open-label, randomized study to evaluate the difference in neurocognitive side effects between Envarsus and immediate release tacrolimus. Eligible patients will be enrolled within 8 weeks post-transplantation. They will be administered a baseline panel of neurocognitive tests. They will then be randomized to either continue on immediate release tacrolimus or Envarsus. 6 weeks after randomization, the neurocognitive tests will be repeated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity
Keywords
Elderly, Neurotoxicity, Calcineurin inhibitors, Tacrolimus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Release Tacrolimus
Arm Type
Active Comparator
Arm Description
Patients will receive immediate release tacrolimus
Arm Title
Envarsus
Arm Type
Experimental
Arm Description
Patients will be converted to Envarsus formulation of tacrolimus
Intervention Type
Drug
Intervention Name(s)
Envarsus
Intervention Description
Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
Intervention Type
Drug
Intervention Name(s)
IR Tacrolimus
Intervention Description
Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
Primary Outcome Measure Information:
Title
Change in neurocognitive side effects
Time Frame
6 weeks after randomization and baseline testing
Secondary Outcome Measure Information:
Title
Change in self-reported side effects
Time Frame
6 weeks after randomization and baseline testing
Title
Tacrolimus dose over concentration ratio
Time Frame
6 weeks after randomization and baseline testing
Title
Kidney graft survival
Time Frame
6 months after transplant
Title
Patient survival
Time Frame
6 months after transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recipient of a kidney transplant
Age 60 or greater at the time of transplant
Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
Have IR tacrolimus as maintenance therapy
Have BMI < 35 at time of transplant
Achieve therapeutic tacrolimus level within 4 weeks post-transplant
Exclusion Criteria:
Recipient of a simultaneous non-kidney transplant (pancreas)
Had an episode of rejection before study enrollment
Had a TIA/CVA after transplantation and before study enrollment
Had a neurologic injury after transplantation and before study enrollment
Blindness
Have an mTOR inhibitor as maintenance therapy
Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels.
Adults unable to consent
Pregnant women
Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling-Xin Chen, MD
Phone
916.734.5141
Email
lxchen@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling-Xin Chen, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling-Xin Chen, MD
Phone
916-734-5141
Email
lxchen@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Olivia Moss, RD
First Name & Middle Initial & Last Name & Degree
Golnaz Friedman, RD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://studypages.com/s/an-experimental-comparison-study-of-envarsus-xr-and-tacrolimus-ir-for-elderly-kidney-transplant-patients-443391/
Description
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A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
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